Sr Manager/Associate Director, Clinical Quality Assurance

Job Title: Senior Manager / Associate Director of Clinical Quality Assurance
Job Description
Join a pioneering biopharmaceutical company at the forefront of RNA cell therapy innovation as a Senior Manager or Associate Director of Clinical Quality Assurance. This role involves managing quality programs for clinical cell therapy assets, with a focus on overseeing Quality Assurance clinical operations. The position requires extensive experience in biopharmaceutical quality assurance, particularly in GCP environments, and a strong understanding of ICH guidelines and FDA compliance for investigational late-stage/commercial cell therapy products.
Responsibilities

+ Lead CQA oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs.

+ Oversee and execute CQA audit planning and perform GCP and PV audits of investigator sites, CROs, and electronic system providers (SAAS).

+ Suppor...