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GMP Quality Assurance Leader; Biologics – AI-Enabled QA
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-07-17
Listing for:
Formation Bio
Full Time
position Listed on 2026-07-17
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Formation Bio is seeking an Associate Director of GMP Quality Assurance in a hybrid New York area role, overseeing all GMP-regulated activities across manufacturing, testing, packaging, labeling, storage, and distribution to ensure compliance with regulatory requirements and internal procedures.
The candidate will support CMC development, audit CDMOs, perform batch release checks, and drive investigations, with a hands-on leadership style and strong communication.
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