The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for downstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as downstream frontline representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in the following areas;

·        Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·        Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

Genentech Partnering is seeking a Manager / Sr. Manager to join the Technologies Business Development Group. The Technologies Group executes strategic collaboration and licensing agreements to support therapeutic lead discovery and companion diagnostic development by Genentech.

Responsibilities will include working in close collaboration with internal scientific stakeholders to establish strategy and prioritization for accessing external technology platforms, defining key technology criteria, actively seeking out opportunities that meet criteria and coordinating due diligence activities.

The successful candidate will lead negotiations with prospective partners on behalf of Genentech, creating collaboration structures that align with scientific and business needs, and will be responsible for making deal recommendations to Genentech senior management.

The BD Manager / Sr. Manager will work extensively with scientists in Genentech’s Research and Development Sciences departments on technology assessments and due diligence and with colleagues in the Legal and Finance departments on deal structuring, financial valuations and contract negotiations.

This position will report to the Director, Head of the Technologies & Diagnostics Group in Genentech Partnering.

Description

Management Associate, U.S. Commercial Services

Reporting to the Head of U.S. Commercial Services, the Management

Associate will provide high-level administrative support to the Head and leadership team members of the U.S. Commercial Services department.

Job Description:

The Management Associate supports the assigned executive and team (as appropriate) with a variety of group administration and operational activities.

Example Duties and Responsibilities:

- Acts as the departmental "go-to-person" for general operational or administrative questions or Genentech policies U.S. Commercial Services guidelines or other inquiries. There is a strong emphasis on organization and proactive coordination of activities.  

- Complex calendar management including meeting scheduling and resolution of scheduling conflicts

- Frequent interaction and planning with executive-level assistants and their customers

- Manage, plan and execute on key project support for management team, including representing company to wide range of partners and outside vendors

- Provide general administrative and clerical support to all areas in U.S. Commercial Services, as required

- Participate, plan, coordinate and prioritize work within or across teams' in support of department projects and goals using independent judgment and initiative

- Attend and actively participate at staff level meetings as required, coordinate/publish agenda and meeting minutes

- Address problems and develop practical, thorough, and creative solutions 

- Independently create and deliver communications based on general instructions

- Generate, disseminate and maintain departmental documents and information

- Administer and contribute content for the department's communication platforms, including portals, newsletters, and announcements

- Coordinate, schedule and execute departmental off-sites, team meetings, and activities, including cross-functional meetings or events

- Manage deadlines related to business planning as well as other special projects

- Develop, implement and evaluate department work processes and procedures 

- Collaborate with Admin team to support complex projects and deadlines

- Proactively assess travel needs and plans and propose arrangements

- Coordinate, monitor and track department contracts and PO's

- Schedule candidates for open positions within the department 

- Actively participate in the on-boarding of new hires

- Exercise independent judgment and discretion of sensitive/confidential and proprietary 

information

- Actively participate in Global Pharma Procurement and Commercial activities

- Ensure compliance with Genentech policies and guidelines in all endeavor

The aim of this job is to support the global Business Process Owner / Head of CoE for the global Learning Solution to establish and maintain a global Learning Solution across the Roche organization, in particular in your area of responsibility. Located in South San Francisco, you provide consultation to the Business in the assigned regions and functions. You work with the local and functional Business Process Owners to ensure that the global processes and standards are embedded in the respective organizations.  In this position, you support the End-to-End Lead in identifying were process and system improvements are required and scope the   initiatives and projects. You are responsible for the delivery of assigned initiatives for your area and across the Roche world in collaboration with the CHRIS LSO servicing and support organizations.

The main responsibilities are:

• Stakeholder management and consultation to the business in the assigned regions and functions:
• North America  
• Latin America
• Middle America
• NAM and LATAM Commercial Operations
• Pharma Manufacturing (PT)
• Diagnostics Manufacturing
• Act as single point of contact for the business, functional and local BPOs
• Gather needs and areas for continuous improvement based on input from the Business,  and address those to the End-to-End Lead and global Business Process Owner / Head of CoE
• Balance local requirements for the assigned area with those of the global and group functions
• Execute the delivery of assigned initiatives (e.g. E2E) across all regions and functions in close collaboration with the CoE and business counterparts
• Liaise with the CHRIS LSO support and servicing organization on new requirements and on the delivery of initiatives
• Enforce the implementation of end-to-end processes locally and functionally (esp. where no dedicated local BPO exists)
• Provide input to global process documentation
• Support change management

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for assisting the shift supervisor by ensuring production goals are met throughout the day and distributing work assignments to technicians.

Job Responsibilities:
Lead TechnicianLead, coordinate and assign daily operations that include work tasks, breaks, and lunches. Provide coaching and training on technical aspects of the job, best practices and compliance to SOPs.

Assist Supervisor with meeting production quality standards by verifying the environment is in compliance with safe standards and SOPs are followed. Assist supervisor with approvals, communications, and improvements. Identify areas for operational improvement. Provide data to supervisors summarizing schedule status. Resolve employee conflict independently and with supervisor.

Job Matrix
Through knowledge of biopharm technology, processes and the underlying scientific concepts.
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoots, investigates, and escalates complex problems, works with others to implement solutions.

Technician: Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Trouble shoot equipment and process problems.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Use of automation to perform production operations.
Provide support to Manufacturing to meet production demands.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Exhibit detail oriented documentation skills
Communicate effectively and ability to work in a team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

Division/Function: 

GPPS-EACM / Service Provider Mgt

Position Purpose: 

Develops and delivers high value sourcing models and outsourcing strategies on the IxRS service category to support the out-sourcing needs of PD, pRED, gRED, GPS and GMA/gMED 

Main Responsibilities and Accountabilities:

In general

* To develop and refine a strategic sourcing plan for the category including determination, implementation and management of the applicable governance structure

* To liaison with Roche stakeholders (PD, pRED, gRED, GPS and GMA/gMED) to ensure that the Biometrics sourcing strategy is aligned with in-house capabilities, with current and future needs and capacity

* To provide advice and guidance to GPPS Contracts & Outsourcing Business Managers in the development and management of key service area domain contracts as well as to provide advice and guidance to project and/or study teams on this category 

* To manage all individual service provider relationships within the category, including contractual (MSAs), vendor performance and issue resolution

* To lead performance management with service providers and to facilitate/expedite issue resolution 

Specific to IxRS Key Service Area:

* To maintain an oversight of the IxRS category including ongoing management of spend and demand (including identification of efficiency and value adding opportunities). This category includes over time oversight of spent for  also ePRO/PRO 

* To act as IxRS subject matter expert; contribute or lead relevant IxRS initiatives (i.e. cross functional working groups), maintain awareness of IxRS services, developments and providers globally 

The Biomarker team in Early Development has an opening for a summer intern.

Responsibilities may include but are not limited to the following:

Evaluate and develop methods for capture and molecular characterization of circulating tumor cells (CTCs) . 

1- develop methods for identification of CTCs of epithelial and non-epithelial origin, and algorithms for automatic detection of CTCs.

2- evaluate diagnostic markers on CTCs using imaging methods (IF, ICC). 

3- develop methods to isolate single CTCs and evaluate downstream molecular analysis platforms.

• Technical Skills: Actively Provide Strategic Support to Relevant Partners [relevant partners – see above description].

• Conducting Analyses & Scope and Structure Key Environmental Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights.  With some support and guidance from manager provide strategic insights and recommendations to brand by linking learnings across projects. Assess appropriate use of primary and secondary research, leveraging internal expertise and resources as appropriate.
• Presenting Results.  Presents objective insights from analyses to relevant partners up to and including CLC.
• Level of Expertise.  Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above job description) to teams, acting as point person in MAS&S for respective area.

• Collaboration: 

• POD Collaboration: Collaborate with MA&S Partner Groups to deliver a synergistic analysis to provide an integrated perspective.  With some guidance of manager, leverages expertise of POD to provide an aligned analytical viewpoint, adhering to team mission, objectives and norms outlined in POD guide
• Leads Cross-Functional and Complex Project Teams With some manager support, customizes the collaborative pod approach to address complex cross-functional business questions.  Delivers the Industry Analytics value proposition to partners.

• Resource Management and Planning:  Manages contracts and budgets for assigned projects independently.  Align with manager and partners on project expectations and delivers on them with manager support.  With manager guidance, prioritize and plan workload and identify capacity issues proactively.
• Managing Up: Effectively applies judgment to leverage and inform manager in navigating organization and completing work

Specific opportunities available in the following areas:  Personalize Healthcare & Companion Diagnostics; Commercial Assessments; Health Information and Technology (HIT) & Industry Intelligence; Managed Markets Analytics

Industry Analytics participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues related to access, reimbursement, and managed care influence.  Leveraging strong structured problem solving skills and collaborating with partners in Market Analysis & Strategy (MA&S), Managed Care & Customer Operations (MCCO), Government Affairs (GA), and Commercial brand teams, the Industry Analytics (IA) team translates market phenomena into unbiased, astute, and actionable insights, and creates innovative analytical solutions in support of key business objectives and decisions.   

• Provide an objective commercial viewpoint based on in-depth understanding, analysis, and synthesis of qualitative and quantitative primary and secondary information.  Assess the market impact of policy, regulatory, and development trends affecting GNE’s portfolio, including current or emerging trends.
• Navigate a complex internal set of teams and functional groups addressing the future landscape and impact, and have an appreciation for the nuanced role that Industry Analytics plays in this effort.
• Navigate a high degree of uncertainty while effectively communicating a point of view and best estimate for planning purposes.   Comfort with ambiguity and can act without having the total picture; able to effectively pose questions in order to "tease out" information required for decision-making.
• Collaborate with Market Planning, Brand Teams, Government Affairs, Medical Affairs, Regulatory, Legal and Global partners in order to inform and model assumptions, communicate impact, influence risk mitigation strategies, and support company initiatives and messaging on strategy.
  
• Successfully identify appropriate opportunities to employ secondary and primary market research techniques to accomplish the above. Guide and conduct primary market research as needed to inform key assumptions critical to good decision-making.  Have sound knowledge of the strengths and limitations of secondary data.
• Successfully employ structured problem solving and quantitative modeling techniques as required to inform key business questions.

The PD/PT Regulatory Affairs Informatics (FPPR) team is looking for a highly skilled Delivery Service Manager, who will support the Submission Management systems area.  This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills.

Further responsibilities are:

• Applies complex procedures and defined standards to meet current business, customer and technical requirements and leads others in resolution of complex problems.
• Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.
• Develops business/technical critical know-how within area of expertise for the function and is familiar with opinion leaders in the field. Assists in the development of others know-how by passing on knowledge of tools and techniques.
• Supports day to day operations and / or implementation of projects within area of technical expertise, contributes to the implementation planning and may execute some aspects of that plan. Accountable for roll-out of new services or enhancement to existing services.
• Manages incident and problem management processes, release and configuration management according to ITIL. This includes continuous improvement for the management of the services. Acts as the initial point of escalation for incident, problem and change management for the Business Representative (e.g. Business Lead)
• Administers change control procedure and processes. This includes the management of the change control board and oversight of the approved change
• Is well-versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships.
• Is familiar with Statement of Work (SOW) and procurement processes
• Is customer-focused and able to track problems/issues to their resolution with the appropriate level of follow-up to the user community
• Builds and maintains good working relationships with the Business Representative and the client business base , monitors services and providing regular service reports to the FPPR management and business clients

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

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 role of the Validation Engineer, located in San Francisco, is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual to  work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. 

The selected candidate will be responsible to:

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).  This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.

Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.  

Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment

Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units  to identify best practices,  and lead improvement initiatives across functional areas

Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics

Provide change request control and support for legacy GMP systems 

Accountable for developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of the Pharmaceutical Quality system.  Accountable for planning, leading and coordinating activities involved in the implementation, governance, and continual improvement of the Pharmaceutical Technical Operations (PT) Quality Risk Management (QRM) Program including standards, business processes, and tools within the Pharmaceutical Quality System (PQS) to ensure consistent and GMP compliant QRM practices.  Engage in external interactions to influence the development of industry best practices in a manner that provides a competitive and strategic advantage to Roche; monitor the external environment for regulatory changes and emerging issues. 

Lead Knowledge Management and Quality Risk Management function including organizational design and implementation, staffing, talent management, performance management, financial budgeting and financial performance, and execution to meet strategic and operational goal.  Specific focus on developing organizational model to support PQS Knowledge Management program. Direct staff in setting operational objectives and business goals for their respective areas of responsibility. Establish and monitor performance measures and objectives for the function.

Major Responsibilities
• Accountable for the development, deployment, full realization, and continual improvement of the PQS Knowledge Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Includes developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of ICH Q10. Specifically includes implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools.

• Accountable for ensuring that the PQS Knowledge Management program is integrated with other PT knowledge management and business intelligence initiatives.  Influence across matrix to drive strategic approach and decisions at a functional and cross-functional levels.

• Accountable for the development, deployment, full realization, and continual improvement of the PT Quality Risk Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Specifically includes the following: implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools

• Accountable for ensuring integration of QRM throughout the product and process lifecycle, and as an enabler within the Pharmaceutical Quality System (PQS).

• Responsible for proactive identification, assessment and management of Quality and Compliance risk across PT operation to ensure compliance and quality supply to patients.

• Accountable for partnering with customers, key stakeholders and senior management across PT Global Operational Units, Functional Units and sites to a.) communicate and escalate Quality risks, resolve conflicts, and drive value-add risk based processes, pragmatic decisions and practices and b.) ensure the Knowledge Management Program for PQS is appropriately integrated with other knowledge management and business intelligence initiatives across the PT organization.

• Serve as Quality representative to the Integrated Risk Management (IRM) Core Team.  Accountable to work in conjunction with the IRM team to implement, maintain, and continually improve the RM Training and Certification Program.  Ensure all roles involved in QRM activities across all levels of the organization are supported through the RM training and certification program.

• Accountable for implementation, sustainment, and continual improvement of processes that ensure proactive identification and management of Quality and Compliance related risks across PT operations to ensure compliance and quality supply to patients.

• Communicate regularly with appropriate management and decision makers to ensure potential quality or regulatory issues that may affect product quality, patient safety or regulatory compliance are escalated and managed adequately.

• Implement, maintain, and communicate relevant QRM metrics.

• Actively engage in external interactions (including regulatory agencies) to influence the development of industry best practices for QRM in a manner that provides a competitive and strategic advantage to Roche.  Support staff development through targeted participating in industry activities.  Monitor environment...

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

• Lead and manage the global PTD Planning  group. This includes establishing a vision and mission for the group and the global PTD planning network with clear roles and responsibilities for local and global activities, establishing and maintaining PTD planning business processes and planning operations in strong partnership with the PTD functional planners, and conduct regular alignment meeting with the PTD planner community ensuring resource allocation transparency, PTD finance, TDLs and TDT PMs, yearly maintenance of generic plans in Plansource with eRAM update, establishing training for planning functions and groups within PTD, resource planning data analysis and scenario planning to support PTD strategy initiatives. Supports budget cycle from the PlanSource perspective
• Accountable for projects and portfolio reports and portfolio analysis. This includes maintenance of reports, creation and/or retirement, and distribution of reports to meet the business needs of PTD and its stakeholders. Creates strong partnership with Global Portfolio Management aligning the PTD reporting with Corporate portfolio.
• Represents PTD on PlanSource Steering group and drives for PlanSource operational processes updates and change management within PTD.
• As a member of the PTDM leadership team, works collaboratively to establish priorities and directions for PTDM globally. Contributes to the development of department business initiatives and facilitates their implementation.
• Fosters a culture of high performance, trust and collaboration across all PTD planning stakeholders. Builds and cultivates a strong network among PTD functional planners, Finance groups, PlanSource expert groups, TDLs and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.  Helps to surface, analyze and resolve planning related issues and resource conflicts.
• Recruits, retains and develops talent. Establishes and implements training and development plans as required, providing constructive feedback as well. Supports the creation, use and continuous improvement of standard planning systems, tools and processes. Interacts closely with TR&D functional leaders and key stakeholders within the Research and Early Development, Development and Technical Operations organizations.

Purpose:

Accountable for the deployment andrealization of the Quality and Compliance strategy for PharmaGlobal Technical Operations (PT) External Quality Operations CMO - Biologics.

• Directaccountability for Quality and Complianceactivities and organization across PT’s external CMOsfor Biologics
• Leadingdeployment and full realization of the PT QualitySystem requirements through Quality Agreements and Contract  Quality Requirements  with externalCMOs.
• Ensurean objective, proactive cGMPcompliance program is established andoperational.
• Qualityresponsibility for extention ofmanufacturing network into EM (India, Russia, Brazil) and forDevices
• Product qualitymanagement activities
• End-to-end externalCMO - wide Quality Risk management
• Directcontinuous improvement activities ofexternal CMOs toimprove Quality and Compliance performance.
• Sponsor forthe Global Quality external CMO issues management process and system.
• Directlyresponsible for External Quality Operations CMO organization
• Overall budgetand financial performance for External Quality Operations CMO organization.
• Accountablefor demonstrating and realizing Roche’score values and expected behaviors.