Associate Director, GMP QA Operations

Responsibilities

• Serve as QA lead for external manufacturing and testing teams, providing technical guidance and quality oversight
• Represent QA Operations in interactions with CMOs and external partners
• Ensure contract manufacturing activities align with regulatory requirements and industry best practices
• Oversee release activities for Drug Substance Intermediates (DSI), Drug Substance (DS), and Drug Product (DP)
• Lead investigations into quality issues, driving root cause analysis and CAPA development
• Develop, implement, and maintain Quality Systems, procedures, policies, and metrics supporting GMP operations
• Participate in domestic and international audits of CMO sites
• Collaborate with CMC, Regulatory Affairs, and Project Management to align quality objectives

Requirements

• Bachelor’s degree in Engineering, Science, or relevant discipline (Master’s preferred)
• 8+ years of experience in a cGMP environment
• 5+ years of experience in Quality Assurance, preferably overseeing CMO/CDMO organizations
• Broad understanding of FDA and EMA regulations
• Experience with GXP QA systems (change control, deviations, investigations, CAPA)
• Proficiency with MS Office, SmartSheet, or Veeva is a plus

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting muscle and the central nervous system (CNS) to address the root cause of disease.