What are the responsibilities and job description for the Associate Director, Quality Assurance position at Connect Life Sciences?
**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 controls
- Lead 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 teams
- Vendor Oversight
- Cross-functional collaboration
Qualifications
- Bachelor's required
- At least 8 years of QA experience - with at least 5 years in ADC
- Oncology experience
- Strong 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