Senior Manager, Quality Assurance Vendor & Audit Management
Listed on 2026-10-08
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Quality Assurance - QA/QC
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Healthcare
Senior Manager, QA Compliance overseeing vendor qualification, supplier oversight, and GxP audit programs within a cell & gene therapy biotech.
Responsibilitieslead qualification, approval, and monitoring of GxP vendors (CMOs, CROs, laboratories, logistics); develop risk-based audit strategies; manage internal and external audits; oversee vendor performance metrics; support quality agreements and regulatory inspection readiness; drive continuous quality improvements; mentor QA team members.
RequirementsBachelor's in Life Sciences, Pharmacy, or related; 8-10+ years in QA, compliance, or auditing within biotech, cell & gene therapy, or pharmaceuticals; extensive GxP audit and vendor qualification experience; track record supporting regulatory inspections.
High Valueexpertise in GxP vendor audits, vendor management, and supplier quality in biotech; familiarity with FDA, EMA regulations; leadership in a regulated environment; hybrid onsite in Somerville, MA with some travel.
We invite applications for the Senior Manager, Quality Assurance Vendor & Audit Management position located in Boston, MA, United States.
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