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Formation Bio

GMP Quality Leader — Associate Director (Hybrid, Equity)

town of boston, NY

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About this opportunity

Formation Bio lists this GMP Quality Leader — Associate Director (Hybrid, Equity) opportunity in town of boston, New York. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Formation Bio in the New York City/Boston area seeks an Associate Director, GMP Quality Assurance to ensure all GMP activities across manufacturing, testing, packaging, labeling, storage, and distribution comply with FDA/EMA/ICH and internal SOPs. The role supports CMC development, audits CDMOs, conducts batch release, and leads investigations.

The ideal candidate is a hands‑on quality leader with strong communication, capable of navigating a fast‑paced biotech environment and exploring

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