Associate Director, Quality Assurance

**No 3rd parties****Must be eligible to work in the US without restrictions**Serve as the primary QA lead Provide strategic oversight for specifications, analytical methods, batch disposition, deviations, CAPAs, and change controlsLead QA support for manufacturing, conjugation, and CMC development Oversee analytical method qualification, validation, transfer, and control strategy implementation.Review and approve batch records, investigations, and quality documentation from CDMOs and internal teamsVendor Oversight Cross-functional collaboration QualificationsBachelor's required At least 8 years of QA experience - with at least 5 years in ADCOncology experienceStrong expertise in ICH guidelines, 21 CFR Parts 210/211 and 600–680, EMA biologics guidance, and global clinical development regulations.Strong knowledge of biologics and ADC Inspection readiness Vendor management/oversight Strong background in vendor oversight, CDMO governance, and quality systems management.Phase I-III