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Associate Director, Quality Assurance — GMP & CMC Leader

Job in Newark, Alameda County, California, 94560, USA
Listing for: Protagonist Therapeutics
Full Time position
Listed on 2026-09-01
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 175000 - 225000 USD Yearly USD 175000.00 225000.00 YEAR
Job Description & How to Apply Below

Protagonist Therapeutics is seeking an Associate Director, Quality Assurance to lead QA activities for GMP manufacturing and CMC programs. You will provide regulatory-focused QA leadership, review batch records, deviations, and CAPA, and guide cross-functional teams toward compliant product releases.

You will report to the Executive Director QA and contribute to risk-based QA strategies, ensuring inspections readiness and regulatory alignment across EU, FDA, and ICH guidelines.

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Position Requirements
10+ Years work experience
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