Senior Director, Quality Control

Role: Senior Director of Quality Control overseeing analytical and stability strategies for Stoke's RNA-based therapeutics, particularly antisense oligonucleotides for CNS and eye diseases in clinical development. Responsibilities include establishing and leading global QC strategies across all development stages, managing analytical method lifecycle, ensuring GMP compliance, and supporting regulatory submissions (IND, NDA, IMPD, MAA). The role involves oversight of external testing labs, ensuring data integrity, and driving continuous quality improvement initiatives. The senior leader will influence Stoke's quality culture, prepare for inspections, and develop scalable, phase-appropriate QC processes. Reports to the VP of Quality and collaborates closely with CMC, Regulatory, and cross-functional teams. Travel is approx. 20%. Qualifications: BS/BA, MS, or PhD in Analytical Sciences or related field; 15+ years of progressive QC leadership experience in biopharma, with expertise in analytical method validation, lifecycle management, and global regulatory standards (GMP, ICH). Experience with oligonucleotide products and managing CMO/CTL relationships is essential. High-value specifics include focus on GMP-compliant analytical control for late-stage development and commercialization, with a strategic role in supporting Stoke’s RNA therapeutics pipeline. Location: Hybrid, Bedford, MA, moving to Waltham, MA by 2026.