Job Description
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...
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...
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Submit ApplicationJob Details
- Location Gaithersburg, MD
- Job Type Full-time
- Category other-general
- Posted Date July 01, 2026
- Application Deadline July 06, 2026