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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:00408246Job109of363Head of CSV Strategy, PD Quality AuditingSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExecutiveServiceDirect 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 Head of CSV Strategy is responsible for the development and implementation of the PDQA CSV risk-based strategy globally covering all regulated systems used by Pharma global functions, affiliates, and service providers. This role provides leadership and direction to PDQ/PDQA for implementation of CSV Strategy (audit and validation quality oversight) and provides actionable data to Senior PD/IS management based on analysis of data (audit/inspection/risk) and identification of compliance trends. Primary Responsibilities and Accountabilities:* Develop and refine Global CSV risk-based Strategy for audit and non-audit activities* Define the CSV Strategy for PDQA and contribute to the review and revision of the PDQA Strategy document* Develop annual goals and objectives supporting strategy* Define/maintain list of computer systems supporting Pharma Development processes/activities* Develop validation strategy for quality oversight of regulated computer systems* Oversee implementation of risk assessment tools for validation analyst and CSV audits * Contribute to annual audit plan * System (CSV) representative on the PDQA Internal Process Audit Management Team* Support global regulatory authority inspections with a CSV component* Assess specific risk areas on an ongoing basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary* Review audit reports with critical CSV findings* Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks* Contribute to the development and delivery of CSV auditor training, QMS and process validation training * Provides leadership and direction to CSV Strategy team. Motivates and manages team members through setting of team and/or individual goals, provides on-going feedback and performance evaluations* Participates in the PDQA Senior Leadership Team to provide input into the development of PDQA strategy, goals and objectives* Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on CSV related activities/issues * Maintains highest level of awareness, expertise in international CSV regulations and internal policies and SOPsWho You AreEducation/Qualifications: * Bachelor

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