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Dyne Therapeutics

Senior QA Ops Lead, External Mfg & Compliance

waltham, MA

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Job description

Dyne Therapeutics is seeking an Associate Director, QA Operations in Waltham, MA to lead QA activities for external manufacturing and testing programs. You will drive GMP quality systems, risk mitigation, and cross-functional collaboration to ensure compliance.

The role requires 8+ years in cGMP environments, strong regulatory knowledge (FDA/EMA), and experience overseeing CMOs/CDMOs. You will mentor teams, improve batch release processes, and support regulatory submissions.

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Worksite address

waltham, MA, 02254, US

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