Senior Director, Quality Control
Stoke Therapeutics · Bedford, MA +1 more
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Role summary
Stoke Therapeutics seeks a Senior Director of Quality Control to lead QC strategy and operations across clinical development through commercialization of RNA-based therapeutics. The role requires strategic oversight of analytical methods, external QC operations, and regulatory compliance in a hybrid Bedford, Massachusetts position.
What they're looking for
- Extensive QC leadership experience in pharmaceutical or biotechnology development
- Deep knowledge of FDA, EU, and ICH GMP guidelines for phase-appropriate applications
- Expertise in analytical method lifecycle management and oligonucleotide product characterization
- Proven track record successfully managing CMO and CTL relationships
- Experience building scalable, lean quality processes in early to late-stage development
- Strong working knowledge of GMP Quality Management Systems and inspection readiness
What you'll be doing
- Establish and lead global QC strategy aligned with CMC across all product development phases
- Oversee analytical control strategy development for clinical trials, regulatory submissions, and commercialization
- Manage lifecycle of analytical methods including validation, transfer, optimization, and stability testing
- Provide QC subject matter expertise and strategic counsel to senior leadership
- Drive organizational quality culture toward sustained inspection readiness for all QC activities
Privacy & handoff
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