Senior Manager, Quality Control
Stoke Therapeutics · Bedford, MA
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Role summary
Stoke Therapeutics seeks a Senior Manager of Quality Control to oversee GMP testing and stability programs for investigational medicines across contract laboratories and manufacturers. This role ensures regulatory compliance, manages analytical method transfers, and supports CMC teams in Bedford, Massachusetts.
What they're looking for
- Experience managing GMP quality control operations and outsourced testing at contract laboratories
- Expertise in analytical method validation, qualification, and transfer under ICH/FDA/EMA regulations
- Knowledge of stability program design, implementation, and trending for pharmaceutical products
- Experience with regulatory submissions, CMC documentation, and inspection interactions
- Proficiency in developing SOPs for laboratory controls and reference standard management
- Scientific background in analytical chemistry or pharmaceutical sciences
What you'll be doing
- Establish and maintain quality control SOPs for GMP testing, analytical validation, and stability management
- Oversee outsourced GMP release testing at contract laboratories to ensure compliance and operational success
- Lead analytical method transfers, qualification, and validation across the contract manufacturing network
- Support CMC teams in troubleshooting analytical compliance issues and drafting regulatory submissions
- Conduct laboratory investigations and review test results, annual reports, and technical documentation
Privacy & handoff
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