Senior Director, Quality Control

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.

Responsibilities

• 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

Requirements

• 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