Job Details

Location:

Emeryville, CA (Onsite)

Engaging Summary

My client — a fast-scaling biologics CDMO — is searching for a bold, detail-obsessed QA leader who thrives where science meets execution. As Associate Director of Quality Assurance, you'll be the guardian of GMP excellence, shaping quality operations that support cutting-edge antibody development. If you're energized by the pace of biotech, love owning QA systems end-to-end, and want to influence the full product lifecycle, this role is built for you.

Why You Should Apply

• Lead QA operations in a high-impact CDMO environment
• Own batch review, lot disposition, QMS execution, and key quality systems
• Partner cross-functionally in biologics development and tech transfer
• Competitive salary + strong benefits + onsite visibility
• Shape Quality culture as the site continues expanding
  
  

• Maintaining site GMP compliance and documentation
• Overseeing deviations, CAPA, change control, quality agreements
• Leading batch record review & timely lot disposition
• Supporting regulatory submissions and audits
• Working closely with manufacturing, QC, facilities & external labs
  
  

• BS + 7 years pharma/biotech experience; 5 years QA
• Strong biologics/GMP background
• Skilled reviewer, communicator, and collaborator
• CMOs/CTOs experience strongly preferred