• The Senior Regulatory Global Project Manager is expected to serve as a strategic partner with Global Regulatory Leaders (GRLs), work with the GRL and the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions;
• Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team;
• Contributes to the efforts of building templates, tools and processes to optimize filing team performance;
• Serves as business partner for the assigned TA (Therapeutic Area) in PDR, working closely with the TA Head, brings excellent project management service offering to the TAs, and also bring TAs’ request/feedback to the Regulatory Business Excellent (RBE) to help further optimize the performance and service offering by RBE.

• Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need;
• Takes accountability for all project management aspects and works effectively and closely with the GRL or Team Leader;
• Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team’s activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources;
• Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders;
• Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PTS of a filing, and work with team to define a mitigation plan;    
• Effectively facilitates filing team meetings with high quality meeting agenda and minutes;
• Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items;
• Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines;
• Maintains proper online documentations of filing related project documents;
• Assists GRL on preparation, organizing and conducting lessons learned sessions post filing;
• Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO’s project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.

The Position:

The Senior Manager of Employee Giving & Volunteerism

The Senior Manager for Corporate and Employee Giving will create an integrated strategy for sponsorships and service and establish an overall volunteerism approach that better engages our approximately 12,000 employees and meets emerging business needs.  The Senior Manager will interact closely with senior leaders from across Genentech to support the company as a great place to work.

RESPONSIBILITIES:

Apply deep subject matter expertise to establish customized service & volunteerism practices that address business challenges including recruitment, retention and skills development as well as enhancing corporate reputation and general employee engagement.

Drive a cross-functional effort to identify strengths, assess gaps and offer solutions that are unique to Genentech. Ensure understanding of operational issues; actively identify strategic opportunities; recommend decision frameworks and present to senior management.

Drive Genentech’s adoption of best practice and cutting edge approaches (eg Pro Bono & skills based volunteerism);

Create and lead plan for successful implementation and socialization across all key stakeholders. Define and measure progress; develop appropriate first-of-a-kind metrics for success.

Manage support staff for volunteerism & employee giving, including outside vendors and internal contractor staff. Provide support for GNE’s employee-volunteer site-based philanthropic giving teams in Oceanside, etc.

Partner with the Principle Manager for Corporate Citizenship in strategic decision-making to support the design and potential launch of a Signature Philanthropic Giving program for Genentech.

Continue to evolve strategy and objectives to ensure ongoing value to the business

• Organize and facilitate teams to critically review current business processes for quality, simplification and effectiveness and to identify requirements requiring cooperation and support from cross-functional stakeholders/business partners, establishing links between business strategy and process improvement initiatives and use of systems.
• Develop procedural documents, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
• Routinely prepares reports by collecting, analyzing and summarizing information to support portfolio planning and study management activities and decisions.
• Collaborates with local or global reporting teams to create USMA specific reports to ensure accurate data is reported to management and enable good business decisions to drive business success.
• Collaborates with USMA stakeholders and other business partners to ensure appropriate documentation and integration in to process maps.
• Regularly attend cross-functional staff meeting to present system and processes project and process improvement activity status.
• Represents USMA on global systems/processes initiatives contributing to maximize functionality and ensuring alignment.
• Serve as internal advisor to address systems/process related questions and gather information to distinguish requests from true business needs.
• Develops tools, templates and procedural documents to support the tactical application of business processes as required.
• Routinely solicits feedback from users on systems and process enhancements, training and other ways of driving more effective systems/processes integration.
• Provides input to training programs and team effort by accomplishing related results as needed.

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.

Senior Project Manager – IT

The Senior IT Project Management position will be responsible for leading the delivery of technology projects in support of US Commercial Operations. The Senior 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. The Senior IT Project Manager will be responsible for managing 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 Senior IT Project Manager will be accountable for all projects in the Commercial Compliance Solutions portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers. 

Duties:

* Define, plan, and direct the execution of a broad range of technical projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Identify, acquire, and lead multifunctional project teams

* Manage a portfolio of 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 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

* Other duties as assigned

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

The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements.  For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network.  The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity.  The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.

Responsibilities:
¿ Partner with Clinical Operations teams to develop drug forecasts based upon clinical trial assumptions, design, and timelines
¿ Leverage the Generic Forecast Assumption process to apply drug forecasts to future planned trials listed in Plansource
¿ Collaborate with Development Partners to understand partner demand and timelines for trials not being run by Genentech
¿ Initiate product definition forms to enable creation of new planning and execution items in SAP
¿ Utilize clinical forecast tools to consolidate all demand for Roche/Genentech, or CMO produced drugs as well as required Other Study Drug procurement
¿ Utilize SAP to create/communicate a Master Production Plan, a depot Distribution Plan and OSD procurement plan that meets global clinical demand, inventory targets, project budgets, and manufacturing capabilities
¿ Actively participate on TDT teams to ensure alignment of demand and supply plans with TDT development strategy and budget, and capture all project driven demand in SAP
¿ Lead cross-functional Global Supply Execution Teams to drive alignment of activities enabling drug to be packaged, released, and ready to ship; meeting trial First Site Activation goals
¿ Manage inventory and production orders for assigned products; monitoring inventory levels, firming production orders, controlling lot allocations, managing expiration dating
¿ Perform required Supply Planning activities & processes driving cross functional action to ensure all drug supply plans are achieved
¿ Participate in the S&OP process as necessary, leading cross-functional process improvement RCAs

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

Description
The Critical Reagents System (CritRS) in Purification Development is responsible for the purification of critical reagents in support of assay development (for clinical products), assays in support of regulatory filings, the continued support of assays for marketed products, as well as specific reagents that support general test procedures (such as ELISAs to measure host cell impurities).  The candidate will be responsible for protein purification, characterization, and documentation of critical reagent production within the purification group. The work also includes interaction and collaboration with members of other CritRS production and customer groups, and potential support of other projects within the group.

Overview:

The Sales Operations Manager role is to support the assigned business unit or franchise with regular and ad hoc business analysis and reporting of, for example, product sales, market share, market segmentation, reimbursement analysis, and/or other measures of business performance. They work closely with other team members in Sales Operations & Information Management, helping to ensure data quality, accuracy, timely and targeted reporting, optimized database and other information systems operations, which may include regular responsibilities to support ongoing operational management of the sales force automation/customer relationship management systems and processes. They also provide the assigned group with support in customer targeting, field workforce sizing, structuring and territory alignments, sales goal modeling and allocation, sales incentive compensation plan design, and/or payment distributions and administration. Given the nature of this role, they work regularly with cross-functional customers in the

assigned business unit or functional unit, such as Franchise Sales and Marketing, as well as a host of other internal partners and stakeholders, including Market Analysis & Strategy, gCOI (Genentech's Corporate Office of Information Technology), and others.

Key Responsibilities

• Primarily responsible for managing and training on all sales operations deliverables including operations launch planning, analytics, reporting, targeting, alignments, Incentive Compensation and Sales Force Automation for their assigned brand(s)
• Partner with sales management and Field Sales Operations to define and produce analytics that support the business objectives and strategies. Provide periodic reports and detailed analysis to identify drivers behind trends and potential business opportunities
• Develop communication materials to support field sales management on business reviews and sales force tools
• Support and respond to field sales inquiries around data
• Collaborate in the management of all IC operation activities including goal allocation, goal adjustments, IC reports. Partner with Compensation Administration team to validate and process incentive payouts, assess and provide impact on issues affecting field incentive plan
• Collaborate with the Information Technology team to define business requirements and solutions for all tools and deliverables that support the field sales force
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

MSL-Oncology

The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada

Main Purpose of the Position:
The Genentech, Inc., Medical Science Liaison (MSL) functions as a field based member of the Medical Affairs organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Medical Affairs through:
* Relationship development
* Clinical trial support
* Scientific/clinical education and communication

Job Duties/Responsibilities:

General:
*Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information.
*Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
*Represent the Medical Affairs organization to investigator community
*Maintain ongoing long-term collaborative relationships with investigator and thought leader communities

Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.

Customer/Investigator support:
*Respond to and document unsolicited requests for information on our marketed products and products in clinical development
*Represent Genentech products at medical information exhibits during scientific symposia.
*Facilitate investigator and thought leader interactions with GNE Medical Directors

Commercial support:
*Provide internal clinical input and training to Commercial functions within regulatory guidelines
*Provide clinical and scientific support for Advisory Boards
*Content development/scientific review of content and presentation materials, upon request

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 upstream 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 USFL 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 two 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.

This position will support cell culture process development projects in the Late Stage Cell Culture Department, including characterization and validation studies. The candidate will be responsible for designing and executing lab bench-scale experiments (bioreactors, shake flasks, etc.), coordinating and supporting pilot plant experiments, analyzing data, and summarizing the results in technical documents and oral presentations. He/she will also be expected to contribute to the identification and evaluation of cell culture technology development projects and may represent cell culture on multidisciplinary project teams and task forces. He/she will be required to author internal technical, characterization and validation documents as well as deliver high quality scientific presentations to the lab group, department and externally.

Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization.   CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).

RESPONSIBILITIES:

The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.  The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.   The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues.  The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives;  responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools;  manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects.  

The Senior Clinical Coordinator, Franchise Sales bringsclinical knowledge and expertise to the assigned franchise sales team.  The Senior Clinical Coordinator helpsclinical specialists and their customers increase their knowledge andunderstanding of the assigned GNE brand(s); their benefits and use as thesepertain to the relevant therapeutic area/disease state and approvedindication(s).

Reports to: Clinical Coordinator Field Manager

Example Duties andResponsibilities:

*Participates in territory/division/regional businessplanning

*Recommends opportunities to increase account knowledge ofGNE brand(s)

*May provide input into marketing materials

*Actively participates in local clinician groups

*Provides training and education sessions regarding GNEbrand(s) and their approved indication(s). Uses approved training/education materials

*Supports clinical specialists in other ways/means byattending periodic account meetings; helping to further increase accountknowledge of GNE brand(s)

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

Purpose:
• Solve a wide range of difficult validation activities and quality issues that impact multiple functions following cGMP regulations and company standards.
• Identify gaps and declining trends as well as innovate on processes and tools to simplify work and standardize practices.
• Build relationships and teamwork across departments, functions, and organizations to ensure commitment and adherence to PTQ strategies and initiatives.
• Be open-minded to diversity in people and ideas and be customer focused without sacrificing quality.
• Perform assigned tasks and work to achieve company goals and department objectives.

Accountabilities:
• Innovate and develop tools and processes to improve standard work and efficiencies.
• Build relationships to influence and dissimulate PTQ strategies, processes, and initiatives.
• Proactively identify gaps and trends in quality and compliance in order to proactive prevent decrease in compliance for inspections.
• Be open to diverse opinions, ideas, and viewpoints to be in a position to make the best decisions, plan, and executions.
• Balance between customer service and compliance without sacrificing quality standards and quality of work.
• Establish and follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned resources when applicable.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Development and manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on quality systems, processes and issues.
• Collaborate on and author department policies or guidelines.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Be accountable for behaviors as described in companies Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support quality oversight activities

Requirements:
• Process Chance Requests related to accountable computer systems.
• Determine Change level per quality policies and appropriate training.
• Review, assess and approve IT related changes.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Provide guidance to internal and external customers on best practices for executing and maintaining a validation program.
• Develop strategies for new validation projects in collaboration with system owners.
• Develop near-term and long-range plans for the group in collaboration with Management.
• Review and approve applicable validation deliverables.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Present and provide rationale for the validation strategies during internal and external audits.
• Ensure the department is represented on relevant project teams.
• Identify, design, and implement validation process improvements.
• Support internal and external audits.
• Assist senior personnel in support of regulatory inspections
• B.A. or B.S degree (preferably in Life Science or Engineering) and at least ten years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
• Sound knowledge of cGMPs or equivalent regulations
• Ability to interpret and relate quality Standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business...

This position may be filled at a Strategy Manager or Sr. Strategy Manager  level.

Strategy Manager/Senior Strategy Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

• Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share
• Conducts and synthesizes managed care markets landscape surveillance into commercial and market impact
• Provides analytic support for Government Affairs and Industry Analytics; including identification of commercial implications of legislation to support lobbying and forecasting
• Translates implications of reform and other legislation to Genentech’s go-to-market approach; including development and execution of Genentech’s Value Forum
• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives
• Reviews and assesses cross-functional business strategies, plans and tactics.  Influences decision-making regarding Commercial-wide patient access-related issues
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics.  May also be, as assigned, responsible for Reimbursement Outlook
• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans
• Works with MCCO account management teams to develop and communicate the managed care marketing strategy. Works similarly with MCCO’s field reimbursement account management teams to develop and communicate the managed care practice management strategy for physicians and other healthcare professionals in the field
•  Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.
• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners
• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments
• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives
• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
• Executes a number of strategic projects and develops internal points-of-view (POVs)
• Complies with all laws, regulations and policies that govern the conduct of GNE activities