Director, QA GMP Operations

Responsibilities

• Management of external quality operations in support of GMP manufacturing activities
• Manage deviations, OOS and OOTs investigations adhering to cGMP and ICH guidelines
• Review batch records, analytical method reports, and technical reports
• Provide QA support for Tech Transfer and Process Validation activities
• Oversee disposition of GMP batches and interface with the Qualified Person (QP)
• Manage change management and CDMO performance within Quality Agreement expectations
• Drive continuous improvement and inspection readiness
• Collaborate cross-functionally to ensure pre-approval inspection and commercial readiness

Requirements

• Minimum of a BA/BS degree
• 10+ years of experience in GMP Quality Operations in clinical late stage or commercial biotechnology
• Leadership experience managing cross-functional teams
• Experience implementing outsourcing and support models
• Experience with product batch disposition and interfacing with a Qualified Person (QP)
• Strong organizational and communication skills

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.