Associate Manager, Quality Assurance Operations
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Part Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Role:
Associate Manager, Quality Assurance Operations, overseeing external manufacturing quality compliance for cell/gene therapy biopharma products.
Responsibilities:- provide QA support for manufacturing
- lead oversight of CMOs
- review deviations, change controls, and validation protocols
- serve as QA point for product complaints
- monitor quality metrics and drive continuous improvement
- manage Quality Agreements and author Annual Product Quality Reviews
- Bachelor’s in Life Sciences or related field
- 4-6 years QA experience in GMP biopharma or cell/gene therapy manufacturing
- strong knowledge of cGMP regulations, deviation management, and validation
- experience with CMO oversight
- familiarity with lentiviral vectors and biologics preferred
focus on cell/gene therapy, cGMP compliance, external manufacturing oversight, validation, and risk management.
Collaboration:cross-functional engagement with manufacturing, MS&T, QC, and external partners.
Work setup:- hybrid (3 days/week in Somerville, MA)
- on-call support
- occasional travel
Position Requirements
10+ Years
work experience
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