121 Oyster Point Blvd South San Francisco, CA 94080
The Manager, Clinical Quality Assurance (CQA) supports the CQA function by managing the planning, scheduling and conduct of CQA-initiated audits; assisting CQA team with preparation for regulatory inspections; assisting Senior Director, CQA, with management of Quality Events (QEs) and Corrective and Preventive Actions (CAPAs); and providing guidance for Pharma staff in interpreting clinical development regulations and Good Clinical Practice (GCP) guidelines. This position supports a culture of compliance and excellence by working collaboratively with business partners, departments, study management teams (SMTs), vendors to create a team environment that addresses compliance-related issues and corrective actions.
• Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing support and regulatory inspection preparation.
• Minimum of 4 years of experience in regulated pharmaceutical environment.
• Minimum of 2 years of experience in supporting clinical compliance and conducting GxP audits of clinical investigators and vendors.
• BS or MS degree (clinical or scientific discipline preferred)
• Additional training in GxP auditing and computer system validation (CSV) preferred.