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Job Field: Government Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00407982Job163of371PV Strategy Lead, Affiliates, AmericasSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionJob Purpose:The PV Strategy Leads, Affiliates are responsible for the development and implementation of the PV risk-based strategy covering all Affiliates in a region. This role monitors the PV processes and activities at Affiliates in a region through the conduct of a risk assessment, annual audits and support of mitigating actions. It also provides actionable data to Affiliate PV management based on analysis of data (audit/inspection/risk) and identification of trendsPrimary Responsibilities and Accountabilities:To design and implement the Global PV risk-based Strategy for audit and risk assessment activities at Affiliates in a RegionPerforms risk assessment to determine which audits will be conducted and where risk mitigation activities should occur at Affiliates Assess specific risk areas on an ongoing basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessaryDevelop and maintain risk assessment tools (APR)Create the scope document for Affiliate audits for PV processes, collaborating with Lead AuditorAct as a point of contact for Affiliate audits for PV processes, review audit related documents and support lead auditorAssess data/metrics from audits, inspections and risk management activities for compliance trends and risks Develop communication tools (reports/dashboards) for audit and inspection metrics and trendsEscalate significant compliance issues to PDQA ManagementContribute to the development and delivery of PV training Support regulatory authority PV inspections at AffiliatesParticipates and/or leads PV affiliate auditsProvides leadership and direction to PDQ/PDQA and our customers/stakeholders on PV related activities/issues Establish strong partnership/relationship with key stakeholders in AffiliatesSupport PDQ Partner Services in the implementation and oversight of QMS at Affiliates Provide feedback on Affiliate risk mitigation plans/CAPAsProvide quality leadership on complex issues (ie. From CHD) to the Affiliates and PDQA staffContribute to the development and execution of PDQA goals and initiativesParticipate in or lead departmental or cross-functional compliance projects and initiatives as assignedAssists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and toolsMaintains highest level of awareness, expertise in international PV regulations and internal policies and SOPsAssess impact of new regulations and guidance on PV activitiesWho You AreEducation/Qualifications: Bachelor

KEY REQUIREMENTS:

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