Director, QA GMP Operations

Dyne Therapeutics is seeking a Director of QA GMP Operations to manage GMP quality within external manufacturing operations globally and internal GMP operations for development and commercial programs. The role involves oversight of QA activities, ensuring quality of deliverables, and collaboration with internal stakeholders.

Requirements

• Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities
• Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines
• Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs
• QA support of Tech Transfer and Process Validation activities
• Disposition of GMP batches and interfacing with the Qualified Person (QP)
• Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts
• Manage CDMO performance within Quality Agreement expectations and GMP compliance
• Drive continuous improvement and inspection readiness
• Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally
• Adjudicate on compliance discussions and negotiate any required corrective actions
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence

Benefits

• Health insurance
• 401(k) matching
• Paid time off
• Retirement plan