Quality Manager

South San Francisco, CA 94080

Posted: 06/26/2019 Industry: Other Area(s) Job Number: 35728

QUALITY MANAGER

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.

 

Requirements

•  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.

 

Education/ Training

•   BS or MS degree (clinical or scientific discipline preferred)

•   Additional training in GxP auditing and computer system validation (CSV) preferred.
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