Director, QA GMP Operations
Dyne Therapeutics(1 month ago)
About this role
The Director of QA GMP Operations leads quality oversight for Dyne Therapeutics’ GMP manufacturing activities, covering both external CDMOs and internal GMP operations to support development and commercial programs. The role partners with internal stakeholders and the Quality organization to ensure programs progress within regulatory and compliance expectations, and fosters a culture focused on quality outcomes and operational excellence.
Required Skills
- GMP Quality
- External Quality
- Deviation Management
- Batch Review
- Tech Transfer
- Process Validation
- Batch Disposition
- Change Management
- CDMO Management
- Continuous Improvement
+4 more
About Dyne Therapeutics
dyne-tx.comDyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for rare, inherited muscle diseases. With the mission "Repairing muscle, reclaiming now," it aims to create life‑transforming medicines that restore muscle function and improve patients' lives. Dyne advances programs from discovery into clinical development with a focus on genetic muscle disorders (including various muscular dystrophies) and works with partners to accelerate delivery of therapies to patients.
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