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

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00403640Job295of371Manager, QualitySouth San Francisco, CaliforniaJob factsJob functionQualityLocationUnited 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 PositionManage the planning and preparation of staff performing routine and complex validation activities following cGMP regulations and company standards. Manage performance and development of team to ensure achievement of organizational and department goals and a productive environment. Solve a wide range of difficult validation activities and issues that impact multiple functions following cGMP regulations and company stand. Maintain a state of inspection readinessAccountabilities:* Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, system 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 personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.* Provide direction to staff to effective manage and orchestrate validation and revalidation projects for equipment, utility systems, processes and facilities.* Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.* Provide guidance to staff (site level) or to site QA Validation management (corporate level) in the review and approval of:* Validation and revalidation project plans* IT and data change control* Execution of Risk Control for IT systems* Ensure that senior Quality management is aware of significant validation issues that my impact product quality or operations* Monitor and report progress of validation projects to Quality Management* Develop, generate and publish validation status metrics* Serve as technical and strategic resource for a range of validation and change control assignments* Ensure the department is represented on relevant project teamsWho You Are* B.A. or B.S. degree (preferably in Life Sciences) and eight years of relevant experience in the pharmaceutical or biopharmaceutical industry, including three or more years of supervisory experience, or an equivalent combination of education and experience* Demonstrated expertise with computer system validation, risk management, change control, and discrepancy/CAPA management* Sound knowledge of cGMPs or equivalent regulations* Ability to interpret and relate Quality standards for implement 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 objectives

KEY REQUIREMENTS:

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