Quality Manager

South San Francisco, CA 94080

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


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.


Education/ Training

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

•   Additional training in GxP auditing and computer system validation (CSV) preferred.
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.