Location
Cambridge
Posted
June 23, 2026
Commute
Local Area
Local Opportunity Near You!
This job is in your area. Enjoy a short commute and work close to home.
Job Description
GMP Key Responsibilities
- Review and co-approve Quality Technical Agreements with GMP vendors, and ensure any project study changes in scope are appropriately reflected
- Manage GMP documents, review and co-approve batch records, and ensure proper control and archiving of quality-related data
- Work closely with Regulatory Affairs to ensure that all manufacturing and clinical activities remain in strict alignment with current regulatory filings (e.g., IND, CTA, or MAA) and to support the preparation of regulatory submissions
- Product Release: Approve or reject raw materials, intermediates, and finished products, often involving data review and certification. Verify that batch documentation and product specifications comply with the 'Approved' versions filed with Health Authorities before final certification or release
- Investigations: Investigate out-of-specification (OOS) results, deviations, and trends, performing root cause analysis (RCA) <...