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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:00408803Job35of371Team Leader Auditing (Product Development Quality)South San Francisco, CaliforniaJob factsJob functionAdministrative AssistanceLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelManagerServiceDirect 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 Team Lead for auditors in PDQA is responsible for recruitment, management and leadership of department audit staff. Through their leadership and direction, they ensure consistent implementation of PDQA processes and procedures and execution of the audit strategy.Primary Responsibilities and Accountabilities:* Provide leadership and direction to the PDQA audit team in the execution of the department strategy* Recruit, manage, train and develop staff* Motivates and manages team members through setting of individual goals, provides on-going feedback and performance evaluations* Oversee staff expenditures* Collaborate with other Team Leaders to resource and manage the audit program * Support auditors in role of Program Contacts * Provide leadership to the Genentech GLP QAU compliance professionals* Manage resources according to department strategy* May participate on audits as necessary (staff evaluations)* Contribute to the development and execution of PDQA goals and initiatives* Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned* Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools* Ensure consistent execution of PDQA strategy, processes and procedures* Oversee execution of department strategy* Review staff deliverables (audit plans, audit reports, quality plans, etc)* Functions as an audit report reviewer for outsourced CTC Compliance audits* Provide GCP, GLP and PV compliance advice to staff * Ensure audits are conducted and reported in compliance with departments procedures* Support regulatory authority inspections* Escalate compliance issues/risks to PDQA Management* Maintain knowledge of HR Corporate policies and procedures* Maintain knowledge of current regulatory, GCP, GLP and/or PV regulations and guidelines and company policies, SOPs and proceduresWho You AreEducation/Qualifications: * Bachelor

KEY REQUIREMENTS:

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