Senior Manager, GMP QA Operations

Responsibilities

• Oversee release activities for Drug Substance (DS) and Drug Product (DP), including batch record review and disposition decisions
• Assemble product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness
• Represent GMP QA in interactions with CMOs, including governance meetings and operational discussions
• Monitor vendor quality performance through defined metrics and ensure adherence to GMP requirements
• Lead and support GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification
• Partner with internal teams to support change management activities impacting manufacturing and testing
• Develop and track Quality Operations metrics (KPIs) for Management Review
• Collaborate with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectives

Requirements

• Bachelor’s degree in Engineering, Science, or relevant discipline (Master’s preferred)
• 6+ years of experience in a cGMP environment
• 4+ years of experience in Quality Assurance within a regulated industry (Medical Device, Diagnostic, or Pharmaceutical)
• Experience overseeing CMO/CDMO organizations
• Broad understanding of FDA and EMA regulations
• Experience with GXP QA systems, including change control, deviations, investigations, and CAPA
• Proficiency with MS Office and SmartSheet; Veeva experience is a plus

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for FSHD and Pompe disease.