Senior Manager, Quality Assurance Vendor & Audit Management

Role: Senior Manager, QA Compliance overseeing vendor qualification, supplier oversight, and GxP audit programs within a cell & gene therapy biotech. Responsibilities: lead 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. Requirements: Bachelor'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. HighValue: expertise 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.