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Apogee Therapeutics Inc. is seeking an Executive Director of GMP Quality Assurance to lead the global GMP QA strategy as the company transitions from clinical development to commercial readiness. The ideal candidate will have extensive experience in GMP QA within the biotechnology or pharmaceutical industries and a strong commitment to the company's C.O.R.E. values.
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Job Summary
Serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness.
Build and lead a high‑performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management.
Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH) and lead organizational readiness for GMP internal audits and regulatory inspections.
Matching Summary
Match Score: 75
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Apogee Therapeutics Inc. is seeking an Executive Director of GMP Quality Assurance to lead the global GMP QA strategy as the company transitions from clinical development to commercial readiness. The ideal candidate will have extensive experience in GMP QA within the biotechnology or pharmaceutical industries and a strong commitment to the company's C.O.R.E. values.
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Salary
$275,000-$305,000
Skills & Requirements
Must-have
Global GMP QA strategy
cGMP regulations compliance
Quality systems design
Cross-functional team partnership
External manufacturing oversight
GMP QA risk management
Nice-to-have
Shaping company culture
Professional growth opportunities
Commitment to C.O.R.E. values
Key Requirements
15+ years of progressive GMP QA experience
Proven track record leading GMP QA through clinical to commercial transition
Experience building and scaling GMP Quality Systems