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Protagonist Therapeutics

Associate Director, Quality Assurance — GMP & CMC Leader

newark, CA

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Job description

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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Worksite address

newark, CA, 94560, US

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