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.

Category Lifecycle Process Leader, Director of Procurement

Location:  San Francisco or Basel

Purpose

* This leadership role is responsible for leading a team in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable for design and delivery of the global category management process. 

* This leader has strategic accountability for the overall category management process for GPP, and must work with SRO leaders to ensure the process connects to the Source to Pay Process. 

* Key accountabilities include creation of a GPP category management tool kit and sourcing, supplier relationship management and governance processes.

* This leader will be responsible for creating and implementing an overall outsourcing process, strategic framework and governance management, which will require engagement with GPPLT and key business leaders. 

* This leader will be responsible for creating and implementing the Global eSourcing Program to establish eSourcing as way of working across GPP. 

* Drives sustainable savings and eSourcing process automation across affiliates, sites & GPP functions through partnership and collaboration.

Key Relationships

* GPPLT, and functional teams

* GPP business process owners

* Affiliate Procurement Leaders

* Global/Regional/Affiliate Finance Leaders

* IT and the S2P Steering Committee

Key Responsibilities

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

* Manages 4-5 direct reports with total team of 10-15 employees and contractors .  Expand to 6 direct reports as Outsourcing Strategy and governance is established.

* Ensures the application of the GPP Category Management process is robust and established as a way of working through the Global Pharma Procurement functions. 

* Establishes and manages the Outsourcing process and strategy governance.

* Manages the connection through the coordination of the overall Procurement Processes of Category Lifecycle including Category Management, Contracting, Request to Pay and Master Data processes.   

* Manages the global category management process ensuring toolkit application and practice for both indirect and direct materials processes.  

* Manages process content and training materials for the category management and eSourcing processes.

* Establish and governs the Supplier relationship management and governance processes for GPP categories.

* Owner of the eSourcing Process:  Including improvements, system (IT Solution), Delivery of support and project portfolio.

* Sets up the eSourcing regional support model to support end to end eSourcing processes.

* Drives the adoption of eSourcing tool and processes globally.  

* Raises usage of eSourcing to increase effectiveness (deeper value) and efficiency (faster cycle time) through the use of eSourcing.

* Establishes and monitor global eSourcing targets in conjunction with savings targets.

* Identify eSourcing opportunities in conjunction with the GPP Categories.

* Manages sourcing project content and strategy including: project and bidding strategy, spend segmentation, recommendations for savings implementation, tender development (RFI, RFP, RFQ, auction formats) and managing multiple site project teams.

Lead process improvement projects at supplier sites as part of Supplier Management process, CMO light

Working with Genentech technology transfer teams lead:

•      Raw material transfers to CMOs

•      Raw material transfer from customers (insourcing projects)

Responsible for SAP management as an SME; provide updates and training of the group in the areas of Supplier and management of raw materials

Responsible for managing, negotiating and completing Quality agreements with suppliers

 Duties/Responsibilities:

·         Troubleshoot and direct the resolution of raw material Quality issues by fostering effective interdepartmental and cross-functional partnerships. Provide solutions to complex manufacturing, quality and negotiation problems.

·         Develop project plans and establish work priorities to meet targets and timelines.

·         Identify, design, and implement process and system improvements.

·         Manage department and cross-functional initiatives and activities.

·         Apply, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems related to chemical and component materials.

·         Serve as a technical subject matter expert (SME) in raw material and component requirements/specifications review and approval.

·         Serve as a trainer and train internal personnel (as needed) on SAP processes related to raw material management.

·         Collaborate and author department policies and procedures.

·         Be able to make decisions using a collaborative and cross functional process

·         Be able to apply good judgment and notify and escalate to Management potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Author, review and approve technical  reports as a result of projects

·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·         Set personal performance goals and provide input to departmental objectives.

·         Manage competing priorities and allocate, adjust, and optimize assigned department resources.

·         Perform any other tasks as requested by Management to support Supplier Quality oversight activities of chemical and component suppliers.

Technical Duties/Responsibilities:

Work with internal, CMO and customer groups and lead the tech transfer of raw materials. 

In partnership with GNE’s critical and standard suppliers ensure uninterrupted supply and internal raw material management groups perform the following technical duties.  .

•      Review Supply agreements and implement Quality Agreements with suppliers (as applicable)

•      Lead and or participate in Business and performance review meetings as applicable

•      Participate in supplier Risk Assessments, and  Supplier Analysis with Procurement (as applicable)

•      Lead  supplier site technical visits to review entire manufacturing processes related to manufacturing of chemicals, components and diluent materials

•      Partner with supplier on internal audits (when possible)

•      Perform supplier audits as needed

•      Write and review technical reports

•      Represent GNE  in customer advisory boards

•      Design and issue supplier business and Quality reports annually

•      SME representative in the SAP team

Location: San Francisco

Research, Facilities, and Procurement Services

Primary Purpose of Job (Job Summary)

The Category/Souring Manager, Facilities Procurement is to provide strategic leadership to the Facilities Procurement organization in support of Global Categories related to Facility Operations and Services.  This position is responsible for: establishing full strategic planning (Regionally and interfacing Globally) on behalf of the Facilities Procurement function in alignment with the Pharma Business and Corporate goals and objectives; identifying and introducing best practices in the Facility Procurement processes; acting as a change agent who supports and influences the business in an effort to create value and efficiencies across the Global and NA Regional networks; focusing on return on investment benefits, Category Lifecycle Management and Total Cost of Ownership; evaluating savings opportunities in partnership with key business partners and stakeholders and maximizing the value of third-party services across a portfolio of sub-categories.  The Global/Regional Category Manager will lead cross functional teams through strategic category sourcing to deliver breakthrough business benefits.

Functional Roles & Responsibilities

The Global/Regional Category Manager, Facilities Procurement will have a Category Strategic and Supplier Management focus of assigned Global/Regional Categories related to Facility Operations and Services.  This position leverages category management expertise to manage the purchases of goods and services, with the aim of achieving optimal total cost of ownership.  This position provides end-to-end strategic solutions, from idea generation through to presentation to senior business management and initiative execution and will fully utilize the eSourcing tools including eAuctions when appropriate to drive the costs down and out across the assigned categories.

Responsibilities:

* Develop strong working relationships with internal teams, key business partners and leaders throughout the Global and Regional organizations/networks.  

* Partner with global colleagues to develop and implement the global category management roadmap.

* Build and maintain excellent relationships with key affiliates, Roche group companies, and global functions so that Roche collectively benefits (e.g. global savings, service delivery, vendor selection, etc.).

* Partnering with stakeholders and business partners to identify and support sourcing projects that reduce risk, timeline, stakeholder pain-points or cost and add value without sacrificing quality or effectiveness.

* Lead and/or partner with various multifunctional teams on strategic initiatives which also include accountability for implementation planning and tracking of expected outcomes.

* Aligning the priorities, activities, and progress of goals across the Facilities organization, so that high value and quality customer service is delivered.

* Provide Strategic Category and Supplier Management:

o Develop an advanced understanding of category subject matters to include Analyzing Category and Supplier Spend history, trends and forecasts

o Establish and manage robust Supplier Relationship Management programs for Strategic/Key suppliers

o Lead Category activities and Sourcing Managers in the development and execution of the spend category sourcing strategies for key initiatives.

o Develop detailed supplier knowledge, market data, including financial performance (P&L, balance sheet, debt structures, trends, history, executives, ownership, parent companies, size, concentration of sales to GNE, diversity of sales volume)

o Analyze past and future demand volumes, inventory trends and current inventory levels

o Document supply-chain for key goods and services

o Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Lead sourcing projects including sourcing strategy development, market analysis, and supplier negotiations, and supplier relationship management

o Monitor Strategic/key Suppliers (earnings, SEC filings, RSS feeds, Alerts) to provide internal notifications to key stakeholders that includes developing risk mitigation scenarios

o Ensure Diversity Suppliers are included in sourcing events

o Know, understand and stay abreast of industry trends, benchmarks, best practices, etc.  Develop and implement a strategy to gain competitive advantage.

* Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations.

* Demonstrate advanced industry knowledge and facilitation skills so that this role leads the negotiations of contractual requirements that includes managing complex RFP/RFIs, making sele...

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.

Support the implementation of Internal Customer Relationship Management process. Leverage knowledge from within PTQS to analyze customer interactions and develop a model for managing interactions between Computer Systems Quality and Informatics.

Currently Informatics performs many activities which we rely upon to ensure the Right-To-Operate. Some of these activities directly support documented requirements for compliance while others do so less directly. Activities vary with complexity and so do the means and ways we interact with each other. Increased variability due to complexity results in less than optimal outcomes. A model for more predictable collaboration, interaction, and participation will improve efficiency, alignment, and customer relationships. An analysis of customer groups and interactions will need to be performed and conveyed via diagrams/charts. The diagrams and or charts will be used to understand the relationships in order to build a governance model for interactions. The governance model will need to minimally include a common understanding of agreed upon customer relationship, basic, concise overarching needs or expectations, and the foundation for: timely communication, appropriate involvement, proper engagement, performance measurement via tool, and decision making pathways.

Key stakeholders will need to be identified. The governance model will be built with customer collaboration. As intern you will be responsible for coordination and scheduling of activities pertaining to the delivery of a governance model, customer relationship mapping/diagrams/charts, and a performance Indicator tool. This means one of the first items after orientation will be to understand the project and then start working on a timeline with actions and planned dates. Your responsibilities will also include gathering knowledge from PTQS SME experts in order to understand best methods for mapping customer relationships. Working together with PTQS and customer to complete the mapping/diagrams/charts. You will need to research performance tools available inside the company and externally and are responsible for providing a list of optional tools and a comparison of benefits for each tool based on the expected use. As intern you will draft a governance model framework as defined by the sponsor, which will subsequently be collaboratively detailed by the customers. You will be responsible for communication and follow up actions with stakeholders.

Strong communication, presentation and organizational skills are necessary.

Intern Project Deliverables

Customer Relationship Management (CRM) governance model
Customer relationship mapping/diagrams/charts
Performance Indicator tool
Presentation of the project which illustrates the work performed, deliverables completed, and value provided

Solution Architect – Regulatory

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

The Position

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

• Works with others to assess existing learning & development curricula and specific programs and other offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; providing detailed partner/stakeholder input that helps shape the direction, specific offerings, as well as content and facilitation methods/structure for ultimate design and facilitation alignment
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, programs or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development plans, programs, and activities
• Translates annual or other cycle learning & development plans, programs & activities into a scheduled calendar of specific sessions/dates for facilitation. Supports manager, peers, team members and others however necessary to finalize and disseminate such calendars, as well as respond to any internal client or external partner questions, concerns, or other comments
• As and when requested, supports others in the development and implementation of an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate department's offerings and support strategies
• Actively pursues continued education and awareness of field, product, disease state(s)/indication(s) and surrounding marketplace changes/developments, and uses where appropriate to incorporate into program and other learning event/activity facilitation, as well as provide such information to manager and team members for continuous departmental review/assessment of existing learning & development offerings
• Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
• Uses approved learning & development plans, curricula, schedule/calendar, specific programs and activities for assigned responsibilities to proactively learn program/other activity content and prepare for expert facilitation. Channels questions, other needs or challenges - in advance - to the appropriate partners; further ensuring full and exacting preparation for expert delivery of assigned learning/development content
• As approved, conducts regular field visits, working with field staff and management one-on-one or in teams. Provides field consultation, team and/or individual coaching and development; enabling hands-on learning/development support to the assigned employee/management groups
• Continuously assesses and evaluates impact and overall effectiveness of facilitation responsibilities. Does so by consistently reviewing learning program participant evaluations, as well as soliciting additional or other feedback, extracting key themes, patterns and opportunities and channeling such to the appropriate internal partners or stakeholders
• Works with peers/team members to ensure maximum leverage of existing resources, tools, programs, content, etc.
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

• Assesses existing learning & development curricula and offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May develop, manage or individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; enabling self, team, department and overall function with detailed partner/stakeholder input
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, specific programs and/or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development support
• Works with others to develop and implement an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate team's offerings and support strategies
• Works with others to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or other
• Works with manager and peers, and oversees team in such a way as to, continuously assess and evaluate learning & development plans and activities to ensure continuous, strategic alignment to meet or exceed internal business partner and other stakeholder needs and objectives
• Consistently monitors and supports team's work and associated work output. Regularly coaches, advises and gives further direction to help team members fine-tune and hone their work to meet or exceed assigned goals and objectives
• Ensures self and team members, where and when appropriate, seek regular internal client or other partner/stakeholder input into in-development work; does so to ensure maximum alignment to internal client needs, objectives and goals
• Consistently oversees the execution/implementation of team's work to ensure timely and best quality output. Manages similarly with any applicable external partners; ensuring their work is on-time, on-target and within-budget to meet or exceed assigned goals, objectives and other expectations
• Hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities