Senior Director, Quality Control
Dyne Therapeutics · Waltham, MA
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Role summary
Dyne Therapeutics seeks a Senior Director, Quality Control to lead QC strategy and execution supporting clinical and commercial manufacturing of neuromuscular disease therapeutics. The role ensures GMP compliance, inspection readiness, and analytical oversight across testing laboratories while collaborating with cross-functional teams.
What they're looking for
- Extensive quality control and GMP compliance experience in biopharmaceutical manufacturing
- Leadership experience managing quality control operations and external testing relationships
- Strong knowledge of analytical testing, release testing, and stability protocols
- Experience with regulatory inspections and maintaining inspection-ready operations
- Cross-functional collaboration skills with manufacturing, regulatory, and supply chain teams
What you'll be doing
- Develop and execute quality control strategy for clinical and commercial manufacturing programs
- Ensure global GMP compliance and readiness for regulatory inspections
- Oversee analytical support and testing activities across external laboratories
- Partner with contract manufacturing organizations on quality and process improvements
- Collaborate with manufacturing, regulatory affairs, and supply chain on product lifecycle management
Privacy & handoff
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