Position Summary:

Provide Project and Program Management for IT business solutions that have significant impact to the enterprise in North America ERP Demand to Supply, Manage Finance, and Order to Cash solutions.

The position will work closely with the North American ERP organization to plan, manage and deliver process and system initiatives. As a senior project manager this individual will lead the deployment of SAP systems and processes across Pharma in the North American region. Responsibilities include future SAP site implementations, enhancements, functional transformation projects and infrastructure related projects.

This position provides expertise needed to effectively implement projects and continuously improve processes. This individual will also partner with business project managers while working with the Pharma IT organization to drive requirements and successfully complete projects.

The purpose of the department is to a) provide IT services for the NA regional ERP solutions, b) deliver enhancements and projects for the regional ERP solutions, c) ensure the services are delivered to established customer SLAs, and d) provide a local/regional presence for the ERP IT group.

2-3 most important contributions of this department

Understand the local and regional business needs for the ERP solutions. 
Deliver operational services for the regional and local Demand to Supply, Manage Finance, and Order to Cash solutions.
Deliver enhancements and projects for the Regional Demand to Supply, Manage Finance, and Order to Cash solutions.

Main customers are the regional/local Finance group, regional/local Tech Ops group,  Local Order to Cash group.

Main PI collaborations are with ERP Architecture, global ERP Solution Owners, Business Project managers, IT Application Technical Leads,  AE&O.

Major Responsibilities:

• Developing work plans, managing deadlines and coordination of project team and sub-team activities
• Estimating project skill requirements, and then working with resource deployment managers to identify appropriate resources and manage their integration into the team
• Defining and agreeing on deliverables , risk management and milestones
• Setting and controlling scope
• Communicating status and vision to client management and stakeholders
• Create a collaborative environment which promotes communication across the organization, at all levels: including but not limited to the Steering Committee, Enterprise Architecture, Departmental Managers and Information Technology.
• Provides overall team management, including regular evaluations
• Prepares and delivers executive presentations and facilitates workshops/meetings.
• Ensures procurement and sourcing procedures are followed.
• Provides Functional Manager with feedback on team member performance.

Job Purpose:

The IT Business Systems Analyst (BSA) position in the Patient & Physician Solutions team will be responsible for the delivery of technology capabilities for the Access Solutions organization in the US, which provides services to help people access Genentech medicines for a range serious conditions. The IT BSA will work on multiple projects for both internally-facing case management tools and externally facing web-based solutions serving physicians and patients, and will be accountable for understanding the needs of customers, developing effective user-friendly designs to meet those needs, and delivering detailed requirements and specifications to drive the development, testing, deployment and production support of IT systems.  

Primary Responsibilities:

The IT Business System Analyst (BSA) will drive the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path.   The IT BSA will assist in determining which methodology path will be most likely to ensure a successful delivery.  The BSA will be responsible for building deep understanding of processes used by medical practices and internal case managers to serve patients, and for integrating the knowledge into the design and delivery of tools to serve all users.  The IT BSA will establish themselves as a “thought partner” with internal customers.   The IT BSA will assure smooth integration with key partners leading the development, testing, training, communication and deployment of technology across the country, keeping management apprised of developments through clear and timely communication.  

Specific responsibilities include: 

• Collaborate with Project Managers, Architects, Engineers, Developers, User Experience Designers and Software Quality Assurance on scope, solutions, constraints, and risks 
• Analyze/document current and future business process models 
• Analyze/document high-level requirements (scope) 
• Analyze/document detailed functional requirements and business rules (use cases) 
• Analyze/document data requirements (from business needs perspective) 
• Support planning of user acceptance test (UAT), including creation of UAT scripts 
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed
• Lead business stakeholders and other business systems analysts thru the business analysis lifecycle

The Position

The IT Project Management position in the Patient & Physician Solutions team will be responsible for leading the delivery of technology projects in support of the Access Solutions in the US, which provides services to help people get access to Genentech medicines for a range of serious conditions.  The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path. The IT Project Manager will be responsible for supervising work by the assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The IT Project Manager will be accountable for projects in the Patient and Physician portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers.

Primary Responsibilities:

• Define, plan, and direct the execution of technical projects, balancing the competing demands of scope, time, cost, quality, resources, and risk
• Identify, acquire, and lead multifunctional project teams
• Manage multiple projects, in addition to individual projects assigned to the position
• Ensure project objectives/requirements are clear and agreed to by all stakeholders
• Manage relationships with various technology and business communities to achieve project objectives
• Facilitate project management activities across the entire project management methodology
• Establishes and maintains effective communication for assigned projects and with dependent projects
• Ensure successful and timely completion of deliverables
• Track progress against baseline schedule
• Plan, baseline and control costs to ensure projects are completed within approved budget
• Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet relevant Computer System Validation directives
• Suggest improvements where necessary / appropriate to improve operational efficiencies
• Conduct risk management planning, identification, analysis and monitoring on projects
• Formulate risk mitigation strategies and recommend solutions
• Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems
• Assign and supervise project activities to the team leads and team members.  Communicate and coordinate assignment and resource-related issues to Genentech management and resource vendor representatives.
• Other duties as assigned

Department:   Site Services
Cost Center Name:  Site Engineering
Based on candidate experience the position can be either leveled as a Principal or a Senior Program Manager (E5/E4)

Responsibilities:

This position manages and directs a portfolio of construction projects <$10M at the Genentech South San Francisco campus (including Dixon and Redwood City). The program manager is the direct interface between an internal Genentech customer group and the Site Engineering outsourced project delivery service provider on each project within their portfolio and is accountable for the successful delivery of the entire portfolio while ensuring a high level of customer service.  The program manager role is strategic, customer facing, and leverages performance management principles to accomplish the work.  Key responsibilities include:

Customer Interface and Project Planning
The program manager is the direct interface between Site Engineering and the key representative(s) of a major Genentech functional group such as Research, PTD, Workplace Planning, Facility Operations & Maintenance, SSF Production, Energy Program and EH&S.  The program manager will be highly engaged with the customer to assist in developing new project scopes, providing input on initial costs and schedules for that customer’s portfolio of work (cLRP level estimates), and assist the customer in driving project starts.  To support this work in the Planning/Project Initiation stage, the program manager will engage resources as appropriate for constructability reviews, alternative analysis, scheduling, estimating, etc., to assist the customer in creating initial scope documents, which capture the initial scope, schedule, estimate, conceptual layoutsplans and key planning assumptions.  Service Level Agreements are developed and adhered to for the specific customer group.

Portfolio Management
The program manager will be responsible for the portfolio of projects executed for their customer group, overseeing all of the projects from planning stage to closeout and completion. The program manager will work with the project delivery service provider to assign projects to project managers from the service provider, and will be engaged with the status of each of these projects, providing input and strategic direction between them based on customer needs.  The cash flow and budget & resource management of the functional area’s portfolio shall be the responsibility of this role, as will assisting the customer in prioritizing their portfolio to meet available project resources. A key deliverable for the program manager will be the creation of a portfolio financial report, detailing the budget and cash flow status of the portfolio on a monthly basis.

Project Delivery
The basic function of this position is to ensure delivery of innovative and cost effective design and construction strategies for various construction projects at the Genentech South San Francisco campus (including Dixon and Redwood City) for each internal customer group.  The project portfolio consists of multiple small projects with total project costs up to $10M each. The typical program manager’s portfolio consists of 40-60 active projects at any given time, and totals approximately $12M-$20M of annual spend. The projects are delivered through a third party supplier who operates within the limits established by agreed upon scopes, budgets, and schedules of approved projects and makes decisions to control the work within these limitations.  The third party supplier executes projects through established project delivery processes, which includes key stakeholder engagement in defining project requirements and scope, business case justification, economic evaluations required to secure financial approval, and ensuring that projects meet intended functionality while controlling costs. The program manager works with the customer to define the project at a high level in the “Project Initiation” stage, and passes it to the project delivery service provider to initiate the project into the “Concept Design” stage, where the service provider takes over full responsibility of the project through completion.  The program manager oversees the work of the service provider with performance based / performance managed oversight.

Finally, a key role for the program manager is leadinggiving presentations to upper management to obtain funding for each project, usually in stages (i.e design phase funding, then construction phase funding). The service provider will prepare initialdraft presentation materials for the program manager, but final presentation creation and delivery to management is a key role of the position. The approving audience will consist of the Site Services Vice President and Directors. For proj...

• Coordinating meetings and events making travel arrangements, preparing reports and interacting with customers and vendors.
• The SAA must be able to utilize good judgment in managing calendar appointments and access to Manager’s schedules.
• The SAA will also be responsible for coordinating, assembling and packaging presentations, agendas and other meeting materials.
• The SAA will be expected to manage conference room scheduling and coordinate meetings with other Managers within GI and across the Company.
• They must be professional in demeanor and appearance, and courteous and friendly.

Director of Portfolio, Project & Process Excellence 

Location:  San Francisco, CA OR Basel, Switzerland

Purpose

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and has full accountability for driving global prioritization of our GPP portfolio and ensures the effective management of our transformation projects through excellence in project management and efficient processes.

* This leader is responsible for connecting together one GPP project portfolio that includes all GPP projects and ongoing resource management.

* Accountable for the Lean Six Sigma infrastructure by building short and long-term capabilities within GPP to meet the vision of becoming the best procurement team in our industry. 

* Partners closely with stakeholders and customers to collaborate, influence and execute on project and  Business Process Excellence across the entire organization.

Key Relationships

* GPPLT – final portfolio decision maker

* GPP Functional Leaders – functional portfolios feed into GPP portfolio; support BPE projects

* GPP Operations - Support the S2P Business process owners through continuous improvement

* Provide BPE expertise to business partners to support improvement to their processes

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 5 direct reports, with a team of 15-20 employees and contractors.

* Oversight of the GPP Portfolio, Business Process Excellence, Project Management function and dedicated Project Communications support.

* Portfolio:  Prioritizes portfolio projects for GPP globally including resourcing and solution management.  

* Identify and prioritize strategic and operational initiatives to improve GPP’s performance along financial (savings), customer, process and people dimensions. 

* Prioritize the overall GPP IT Solution management and roadmap including maintenance and enhancements.

* Project: Develops a consistent stage gate review process to ensure all projects are set for realization of their intent and sponsorship.

* BPE and Project Support:  Provides vision and guidance to effectively support business process excellence – through achievement, sustainment and ongoing realization of business process management.  Ensure a robust infrastructure to support effective, efficient, innovative and agile operations. 

* Ensures projects achieves its intended realization.  Support overall change execution through the BPE tool kit.

* Builds BPE/OE capabilities and mindset within the network to empower others to make improvements on their own. Train others in the continuous improvement tools and techniques found in the BPE/OE toolkit.

* Communications:  Ensures GPP project and portfolio communications are aligned and connected to the overall GPP communication strategy. 

LOCATION:  San Francisco, CA or Rocky Mount, North Carolina

Description:  This particular position of Principle Site Manager in the North American Steriles CMO organization will have the primary responsibilities of site management of Drug Product Diluents at a Contract Manufacturer.   This role will be a position that will be the “Person in the Plant (PIP)” located in Rocky Mount, North Carolina. 

Job Responsibilities:

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as the Roche/Genentech’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, ...

• Serve as the Site Manager overseeing clinical contract manufacturing organizations (CMOs) or clinical distribution organizations (CDOs) that are needed to meet clinical supply requirements in supporting clinical labeling and packaging. 
• Lead and collaborate with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives in addition to performance goals for the contract manufacturing or business partnerships.
• Manage the operational activities of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. 
• Develop solutions to complex issues with inter-organizational impact.
• Prepare Requests for Proposals (RFPs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
• Support development and continuous improvement of the supply relationship with IMP CMOs/partners.
• Position may be filled as an E3 or E4 depending on candidate’s experience and qualifications.

Responsibilities:

• Responsible for overseeing execution activities of clinical contracting manufacturing organizations (CMOs) to support labeling and packaging outsourcing activities for clinical studies. Scope is from release of DP at the Filling site through release of Final Packaged Goods at the label/pack site; scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary DP materials and FG components are available for execution.
• Ensure reliable supplies of Final Packaged Drug Product (including Other Study Drugs as required) to our customers and our patients, while meeting acceptable quality standards and Genentech’s financial and development goals.  Proactively intercede if goals and timelines are jeopardized.
• Coordinate operational activities with internal cross-functional teams (Clinical Planning, External Quality, Distribution) to ensure on time release of packaged clinical product.
• Participate on cross-functional teams in evaluating and selecting CMOs for a particular project as requested. 
• Prepare a Statement of Work (SOW) as required.  The preparation of an SOW can include negotiation of project fees, negotiation of milestones, defining responsibilities between Genentech and the CMO and keeping Legal, Procurement and other groups up to date on SOW progress.
• Provide input to the internal CMO/partner SPOC ensuring that the overall relationship between Genentech and the CMO/partner is healthy. 
• Develop, maintain and drive key health metrics between GNE and the CMO to ensure effective and continuous improvement of business performance and relationship.
• Participate in Master Service Agreement creation and maintenance as requested so that it accurately reflects the existing business relationship.
• Proactively identify risks.  Create strategies to avoid or minimize their impact.  Manage the execution of risk mitigation plans. Participate in and contribute to drug development telecons in an effort to proactively intercede if a relationship issue jeopardizes the project.
• Create purchase orders.  Review and approve invoices for GNE payment and coordinate on-time CMO payments.  Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis.
• Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
• Report as needed on performance and operations at Operations Review.
• Support External QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• International and domestic travel as required. 

Requirements:

• Collaborative Leadership - Ability to strongly influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.
• Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly.
• Communication - Ability to communicate effectively at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity.
• Planning/Organization - Excel...

The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation. 

Job Responsibilities:

* Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System

* Liaises with technical groups to review and revise specifications based on design and/or process changes

* Supports root cause analysis in the implementation of corrective actions

* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools

* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products 

* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.

* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.

* Responsible for planning, organizing, and managing the overall testing activities of quality functions.

* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). 

* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.  Perform any other tasks as requested by Management to support Quality oversight activities

* Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.  

Main Purpose of the Position

Description:  This Site Manager will manage the Production oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMOs) located in Greenville, North Carolina.  This person will be a team leader on a CMO governance team to support right to operate and supply of critical biologic products, including a product launch.  

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as a point of contact for the contract manufacturing relationship at the Joint Management levels.

* Lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Participate in and/or Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including potential to serve as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management. Lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche/Genentech Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments suppor...

Primary Purpose of Job (Job Summary)

> Build up and maintain best-in-industry global procurement risk management and business continuity management in close collaboration with GPP Head of Compliance, Sustainability & Supplier Diversity, the Roche Group Risk Advisory Team and the GPP Head of Risk Management.

> Develop risk management strategies, programs, processes, tools and systems that are in line with the Procurement Sustainability program in order to increase the resilience of suppliers involved in the supply of Roche’s medicines and diagnostics to patients and deliver value to stakeholders. 

> Manage and mitigate the risks related to Roche’s suppliers and ensure their commitment to sustainability by including sustainability and risk management into supplier relationship management.   

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Lead Global Pharma Procurement Risk Management and related strategic initiatives

* Deputize Head of Sustainability, Risk Management & Compliance in Risk Mgmt related topics

* Lead the development and roll-out of sustainable procurement risk management  processes, tools, systems and programs in GPP in close collaboration with Group Risk Management and with category, regional and site procurement heads

* Lead the global risk management governance in GPP, including compliance with GPP risk management policies, processes and training of GPP staff

* Align with Diagnostics and IT Procurement on risk management strategy and related topics

Functional Roles & Responsibilities  

* Develop GPP risk management processes, tools, metrics and systems in close collaboration with Roche Group Risk Management, category, regional and site procurement as well as other Group functions involved (e.g., Group SHE, Finance, Legal, Quality)

* Influence Roche overall global sustainability & risk management programs and contribute to DJSI submissions

* Facilitate identification, evaluation and mitigation of procurement risks in close collaboration with Group functions, category, regional and site procurement heads and the related business partners

* Develop and keep up to date training content (including e-learnings) on procurement risk management to GPP staff and collaborate with Dia, IT on this

* Facilitate joint risk assessments of Roche procurement & sourcing teams with suppliers

* Design global business continuity management for GPP including crisis management, incident response plans and war room playbooks and facilitate implementation

* Drive compliance with the GPP Risk Management policies & processes, the Roche Group Risk Management Process and risk-related Roche Group Policies & Directives

* Support the business process managers with identification, evaluation and treatment of procurement risks related to products, materials/ services and/or suppliers in close collaboration with the stakeholders

* Ensure timely communication and reporting about procurement risks with key stakeholders, including Dia & IT Procurement, business partners and external stakeholders

* Build strong network with Group Risk Officer & team, category, regional and site procurement heads and other functions involved (e.g., Group SHE, Finance, Legal, Supply Chain, Quality)

Working Relationships

Key internal interfaces:

* GPP Head Sustainability, Risk Mgmt & Compliance

* Category, Regional & Site Procurement Heads

* Roche Group Risk Officer & team

* Head of PT Integrated Risk Management & team

* Diagnostics & IT Procurement

* Group SHE, Finance, Legal

* Supply Chain, Logistics, Quality 

* Risk Managers in procurement and other functions

Position is responsible for the development, maintenance and advancement of the Enterprise Resource Planning (ERP) system recipes and master data used by SSF Clinical Supplies Management.  Successful candidates will represent the department as a subject matter expert and liaison between a variety of key internal and external stakeholders.  They will lead processes to ensure successful SAP data development, deployment, and maintenance and will ensure appropriate integration of CLARA, R3, and APO with supporting systems.  The successful candidate will be adept at leading cross-functional teams in problem identification and resolution.  They will be relied upon to work collaboratively and independently to solve emerging challenges inherent to rolling out new data applications.  The position will provide support of user needs for current and future applications for the Clinical Supplies Management department.  They will represent the department in interactions with the global business process management community and will proactively identify areas for improvement.  Additionally, the successful candidate will play an important collaborative role in the integration of the newly formed production services team.  To this end, the successful candidate must also demonstrate competency and/or aptitude as well as interest in broader aspects of materials management, master production scheduling, capacity management, and detailed scheduling.  In addition to their system expertise, they will bring a willingness to learn new skills and tasks that will allow them to successfully backfill other production services roles in a dynamic environment.

Job Responsibilities

Scope of Work - The Business Analysts will be responsible for creating the SAP Recipe in collaboration with data owners to enable materials and capacity requirements planning and successful execution. Responsibilities of this position include:

*Develop SAP recipes for load into system
*Coordinate and lead data strategy and execution meetings with site and network representatives
*Provide technical solutions to a variety of problems of moderate scope and complexity.
*Develop solutions that are imaginative, thorough, practicable, and consistent with organization’s objectives
*Adhere to change management processes to ensure data accuracy is maintained across systems
*Provide reporting and analysis required to manage key performance indicators
*Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
*Provide training on usage, enhancements and changes to business systems
*Work is performed under limited direction and guidance, with general instructions on new assignments
*Proactively recommend priorities, timelines, and resources for addressing emergent business needs
*Participate in developing courses of action that may impact multiple functions in the organization
*Network with senior internal and external personnel in own area of expertise. Represent organization on assigned projects
*Identify opportunities for improvement
*Lead cross functional and cross network teams in the identification and implementation of improvement initiatives

(External Quality, Commercial Drug Substance)

Sr. Technical Manager, Tech Transfer – Biologic Drug Substances (SSF)

Main Purpose of the Position: 

* Provide Quality oversight for Roche and Genentech products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and Roche/Genentech standards. 

* Serve as the Quality single point of contact for designated CMO(s) and participate as a key member of Drug Substance (DS) CMO governance teams to support site selection, product technical transfers and on-going external commercial site management.

Responsibilities:

* Participate in site selection and product technical transfer activities at CMOs, such as due diligence audits and GMP readiness activities.

* Manage all required activities to support release of commercial product including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls. 

* Develop, negotiate and maintain CMO cGMP quality agreements and ensure compliance with agreements.

* Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.

* Participate in regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs.  Support regulatory filings for products manufactured at CMOs.

* Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required.

* Establish CMO goals/metrics and monitor and report progress. Lead or participate in CMO or cross-functional process & quality improvements projects.

Purpose:

The Head of Small Molecules Development Products, North America, in External Quality is accountable for the development and deployment of the Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the gRED Small Molecules development portfolio. Accountable for all aspects of Quality related to these CMOs to include: Quality Systems, Product Quality Operations, Process Qualification and Validation, cGMP Compliance, Risk Management, GMP Audit and Inspection Readiness. Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche’s reputation as a reliable, high quality supplier of IMP products. In collaboration with other PTx and gRED functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements. Responsible for risk management utilizing risk management tools for each CMO within group’s scope. Accountable for the management of Quality and Compliance within the group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Responsibilities: 

* Management of the North America Small Molecule Development Products Group

* Staff and assign Quality Managers to lead quality teams for IMP products after approval to proceed to development utilizing CMO manufacture 

* Lead Quality Managers in the implementation and execution of Quality processes for the selection, implementation, and ongoing management of development CMOs

* Accountable for the Quality and Compliance Status for all CMOs within the group’s scope of operations 

* Establish and manage performance metrics for the Key Performance Indicators (KPI) 

* Determine staffing requirements and provide input to department budget

* Establish individual goals for direct reports, provide performance management for direct reports, and conduct talent management in accordance with Roche standards and procedures

* Accountable for the deployment of the Roche PT Pharmaceutical Quality System (PQS) standards and requirements for outsourcing for all Small Molecule Development CMOs used for the gRED portfolio, ensuring appropriate risk assessment and mitigation for identified gaps

* Participate in Joint Steering Committees through the established Governance processes as required. Define quality actions to be resolved and/or escalated to Roche senior management at the Executive Steering Committees.

* Accountable for approval of:

* Quality Agreements Appendices, such as PSRs, for Development CMOs on behalf of Roche Quality

* IND and IMPD Manager Level reviews

* Major Deviations or Changes in Roche Approval systems

Purpose:

This Principle Technical Manager will manage the Quality oversight related to sterile diluents manufactured at a Contract Manufacturing Organization (CMO) located in North Carolina.  This person will be a key member of the CMO governance team to support right to operate and supply of diluents packaged with several critical Genentech/Roche products.

Responsibilities:

·         Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of diluent for Roche products.

·         Establish and monitor CMO Quality goals and metrics to drive continuous improvements

·         Recommend, implement, and drive strategic objectives and goals of the CMO relationship

·         Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

·         Manage the release of product, including batch record review, investigations, change controls

·         Partner with the CMO to ensure proper aseptic control during Roche operations

·         Observe end-to end production activities that include filling, terminal sterilization, visual inspection, and labeling

·         Work with CMO to align requirements for visual inspection of diluent

·         Make decisions if issues arise during production

·         Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required

·         Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks 

·         Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS)

·         Participate in regulatory inspections and GNE compliance audits

·         Develop and negotiate Quality Agreement with CMO

·         Support any regulatory filings for diluent manufactured at CMO

·         Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees

·         Serve as the Quality representative on cross-functional and multi-site teams

Primary Purpose of Job (Job Summary)

> Lead and execute on Organizational Communication and Change Management activities in support of projects for the GPP projects.

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Responsible for the assigned tasks on GPP projects globally

Functional Roles & Responsibilities  

* Lead organizational communication and change management related activities across key GPP projects.

* Assess the needs of change management for specific projects and provide recommendations to address the changes and ensure realization of the project scope and objectives

* Align with and utilize Business Process Excellence (BPE) resources and methodology throughout the project life cycle(s). Ensure that objectives and critical success factors are identified, met and measured.  Strive to develop a well-rounded BPE skill set. 

* Identify risks, anticipated points of resistance and potential lack of sponsorship and develop plans to effectively mitigate these 

* Develop actionable change management plans, including risk assessments, stakeholder engagement, communication, and training plans for any assigned projects

* Coordinate with team members, sponsors, Business process managers, local end users/customers, and stakeholders to ensure alignment with project  and GPP vision, goals, and objectives and understand the needs of customers and stakeholders 

* Work with Team members to integrate change management and communication activities into the overall project plan to secure effective and lasting adoption.

* Facilitate meetings, workshops and other events where communication and change management are required. 

* Actively participate and facilitate at all team meetings as a full member of the assigned project team, 

* In partnership with the Business Process Owner (BPO)/Sub Process Owner ensure an effective business review process with all relevant input about prioritization, impacts, cost/benefits, vision and objectives associated with project deliverables and change management/communication.

* Coordinate with Technical teams and business end users across the project lifecycle in all areas associated with communication and change management

* Work individually and in groups with project team members and stakeholders as needed

* Engage and coordinate with training managers and planners. Make sure the Training Materials and information sharing tools consistently reflect updates with regards to change management and communication (e.g. Roche Wiki, Procurement Manual) 

* Build strong collaborative networks with key stakeholders and ensure communication is concise, consistent and compelling

* Ensure alignment of change management approach and stakeholder outreach across related Infrastructure projects, optimizing stakeholder involvement.

* Ensure compliance with global business process guidelines, policies, and governance.  

* Drive for continuous improvement and scalable and sustainable solutions to meet global needs

* Engage as a fully vested member of the GPP team and support all goals and objectives of GPP

Membership in Decision Bodies and Major Internal Working Groups or Alliances

Decision body, working group

Chair

Member

Guest/ affiliated

Global Pharma Procurement Leadership Team

Procurement Services Leadership Team

Procurement Services BPE Leadership Team 

Procurement Services Infrastructure Leadership Team

GPP Communication, Procurement Academy, Change Management Teams

Project Teams/Related Initiative Teams

Working Relationships

Key internal interfaces:

* Site/Function Procurement Heads

* PMs/ Local Systems Managers / Site Champions/BPm

* Business Process Excellence Leaders/Teams

* Finance and Audit

* Informatics Teams (PGSD / PGST / FPSE)

* Business Process Owner / Sub Process Owner 

* End Users/Impacted parties and stakeholders

* Training Resources/Coordinators and Procurement Academy Leaders

* Project sponsors and steering committee members

* 

Key external contacts:

* External resources for training and coaching as required

Purpose:

* The CMO Logistics Specialist acts as a liaison between Manufacturing Collaborations (MC), the CMOs and Genentech’s plants and logistics functions and is responsible for the detailed scheduling of orders and material movements to and from contract manufacturing sites.

* The Logistics Specialist ensures that all materials are available and delivered to the CMO on time in order to support scheduled production and releases orders to allow the CMO (through the MC Site Managers) to execute and to close orders upon completion. 

* The Logistics Specialist monitors the detailed production and shipping schedule in order to identify and resolve any variances that are occurring and coordinate required changes with the CMO. He/she also follows up to identify root causes for such variances and the corrective actions required to prevent their reoccurrence.

* The Logistics Specialist provide support to the CMO with all issues related to logistics and inventory management and provide guidance for material handling and any other questions that arise.

* The Logistics Specialist is responsible to the accuracy of inventory records and status in Genentech’s ERP system for all GNE-owned material that is at the CMO site and works with the CMO to update these records as material movements/consumptions occur.

Responsibilities:

Ensuring material availability for CMO production:

* Perform material requirements planning for multiple sites

* Monitors the detailed production schedule at assigned CMOs to identify material requirements and other preparations required to ensure readiness for production execution

* Coordinates with supplying plants to ensure alignment and understanding of CMO material requirements and shipping dates

* Ensures material availability and/or that production/delivery plans at supplying plants/warehouses are aligned with material requirement and shipping dates

* Coordinates with Quality to ensure that material release/disposition plans are aligned with required shipping dates and monitor progress of release/disposition process relative to schedule and shipping requirements

Transportation scheduling and coordination:

* Creates, converts and maintains Stock Transfer Requests (STRs) and Orders (STOs) and/or Purchase Orders for required materials

* Coordinates and/or schedule shipments with carriers and/or GNE Transportation.

* Works with GNE Transportation Import/Export functions to ensure that international shipments are properly coordinated with freight forwarders or customs agents and that materials clear customs without issues

* Coordinates with warehouse and other logistics functions to ensure that materials are prepared and shipped on time

Logistics schedule management:

* Identifies any delays during the manufacturing/release process that may have an impact on the scheduled shipping dates and works with relevant functions to avoid delays to scheduled delivery dates to CMOs

* Identifies, analyzes and escalates (to Master Scheduler or manager) schedule conflicts or delays that impact delivery dates to CMO 

* Coordinates any required changes with CMO

* Monitors the shipping/transportation of materials to/from CMO sites to ensure successful and on-time delivery.

Materials management:

* Manages and releases process orders to ensure a minimum of 7 days of orders have been released.

* Performs goods receipts of materials into CMO inventory locations upon delivery and monitors CMO inventory and material movements to ensure accuracy

* Performs regular inventor counts with each CMO and ensure updates GNE inventory records if necessary

* Allocates materials to production orders (in coordination with product planners as necessary)

* Provides guidance to CMOs and addresses questions and issues related to material handling, inventory and transportation

Performance management and projects:

* Monitors Key Performance Indicators (KPI’s) and supports root-cause analysis

* Executes all logistics process and other responsibilities in accordance with established business processes

* Identifies areas where existing business processes are not sufficiently defined/documented and/or require improvement

* Works with management to initiate improvement projects to address process deficiencies or improvement opportunities

* Collaborates with various groups and OE resources while working on cross-functional teams to support improvement projects and root cause analyses

* Takes responsibility for action items and tasks arising through such cross-functional teams and root-cause-analysis exercises and executes them to accomplish the team’s objectives 

Position: Principal Business Process Excellence

Location: Basel or South San Francisco

Summary:

Team Overview:

The Business Process Excellence (BPE) team is focused on enabling GPP to achieve Best in Class Performance by taking the lead in the creation and improvement of scalable, robust, and streamlined processes.  Intent is to enable GPP’s Strategy and build robust process capabilities that manifest through the routine delivery of exceptional performance as per business needs. The BPE group partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth. We use a several tools and methodologies within but not limited to Business Process Excellence toolkit to deliver tangible and sustainable business results. 

Position Overview:

This position focuses on using Business Process Excellence methodology to perform business process analysis, design/re-design and optimization to enable the routine delivery of exceptional operational performance

Reporting to the Head of Business Process Excellence - Global Pharma Procurement (GPP), the Principal- Business Process Excellence (BPE) will champion embedding Business Process Excellence across the entire GPP organization and ensuring our organization achieves its vision of becoming the Best in Class within the industry. Person will be simultaneously in a strategic and global execution role to support GPP’s journey towards the Best in Class performance.  Incumbent will partner with clients across GPP & PT on a regular basis, drive BPE cultural change and build BPE capabilities at grass root as well as leadership level.  

Responsibilities: 

This individual will be responsible for leading global cross-functional process improvement projects, representing the department as the change agent, partnering with the customers, leading internal efforts within the team, communicating/coordinating/bringing together key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in best practices associated with industry and BPE methodologies. This individual will be accountable for following and improving upon the BPE methodology. The work will be done in alignment with the company's values and behaviors. 

Requirements: 

* Lead cross functional project teams to: -Create solutions to ensure a continuous improvement culture, including behaviors and measurements using BPE methodology

* Implement practical and sustainable business processes that best serve the business unit -Deliver project goals on budget and on schedule

* Develop conceptual customer needs into an approved project charter

* Analyze business, process and systems performance, and identify improvement opportunities -Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses

* Make recommendations to Senior Management based on business case and analyses

* Lead decision making support and make recommendations regarding best options -Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution

* Develop and use project plans to coordinate participants and track and report progress -Leverage industry research and analysis; serve as advocate, mentor & role model for integrating best practices into the organization -Ensure improvement methodology and tools are utilized effectively to maximize benefits

* Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals 

Competencies:

* Ability to influence with or without direct reports, facilitate groups with diverse perspectives, bring teams to the best solutions. High tolerance for ambiguity, able to create order from chaos. 

* Takes accountability for actions, drives results, and learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?” 

*  Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity. 

* Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite shifting environment.

* Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigatio...

Senior Director, Contracts Process and Operations 

Location:  San Francisco

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable  as the global contracts business process owner to ensure optimal GPP value delivery to our business partners.   

* This leader will be leading an organization that is bringing together all GPP contracts teams into one function to leverage best practices and align with the GPP Go Simple project to streamline contracting processes within GPP.  

* This leader has strategic accountability for activities associated with development and execution of contract agreements for all GPP customer groups globally (Product Development, Research, Technical Operations, Global Product Strategy, US Commercial and US Site Services) 

* This leader is the primary liaison with senior leaders in various GPP client groups and US/EU legal organizations and must be able to effectively influence senior leaders

* Accountable for appropriately managing legal and compliance risk on behalf of Roche in the execution of the contractual process including negotiations of terms and conditions. 

* This leader is accountable for connecting the Contracts process to solutions (IT) and service delivery.

Key Relationships

• Internal: Provides guidance and mentoring to Contracts staff members in contract development and administration and working effectively with Genentech user community and vendors

• Business Partners 

• External: Seeks out industry benchmarks

• IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages  6 direct reports and manage a team over 110 employees and contractors.

* Responsible for developing and implementing contract processes and managing a group of professional contract staff globally representing all GPP functions.

*  Ensures that a wide variety of company contracts are negotiated and processed to meet the needs of multiple client groups.

* Manages the contract process from initial request to contract execution, focuses on agreements with complex legal and business risk.

* Actively manages the GPP Contract process and support the connection to the overall Procurement Processes of Category Management, Contracting, Request to Pay and Master Data processes. 

* Ensures all policies that govern the conduct of contracting activities are adhered to in accordance with all legal policies globally

* Works with Roche/Genentech user community to ensure there is a complete understanding of contract requirements.

* Works with direct reports, other team members, and various internal business partners to review contract service levels and performance.

* Participates in process improvement or other projects that enhance and streamline contracting processes, systems, tools and other resources; collaborates legal departments to improve contract templates and processes.

* Provides direction and training to teams regarding good business procedures and contract business terms; shares best practices and feedback on contract and budget matters to Contracts staff and  GPP teams.

* Identifies and manages areas of risk and compliance both in the establishment of contracts and in the operation of the contracts and the relationship with the outside vendor.