Stoke Therapeutics

Director

• Provide strategic, scientific and operational leadership for Stoke’s Quality Control function
• Establish and lead the global QC strategy across all stages of product development
• Act as a QC subject matter expert and thought partner to senior leadership
• Establish and maintain phase-appropriate analytical control strategies for clinical development, regulatory filings and commercialization
• Oversee the lifecycle management of analytical methods for oligonucleotide products, including transfer, qualification, validation, optimization, stability testing, specification justification, shelf-life management, reference standard management and remediation
• Lead routine GMP in-process, release and stability testing and establish long-term QC testing strategies
• Lead selection, governance and performance management of contract testing laboratories (CTLs)
• Partner with CMC, QA, Regulatory Affairs and Program Teams on overall control strategy
• Provide leadership and technical input into CMC and analytical sections of IND, NDA, IMPD and MAA submissions
• Support interactions with Health Authorities, Stoke partners and CTLs
• Provide GMP compliance interpretation, consultation and training, and ensure data integrity
• Mature QC infrastructure and implement GMP-compliant processes and procedures
• Drive continuous improvement across Quality Control
• Support GMP inspection preparation and mock PAI inspections at CTLs and CMOs
• Influence Stoke’s Quality culture
• Lead, mentor and develop a small team of QC professionals
• Report to the VP of Quality and collaborate with CMC Analytical Development, CMC Manufacturing, Regulatory and other Quality functions

Senior Director, Quality Control