Senior Director, Quality Control

Role: Senior Director, Quality Control leading Stoke's global QC strategy from early clinical to commercialization. Responsibilities: develop and oversee analytical control and stability strategies; manage lifecycle of analytical methods for oligonucleotide therapeutics; lead QC operations including GMP release, in-process, and stability testing; partner with CMC, QA, Regulatory, and external CMOs; support regulatory filings (IND, NDA, IMPD, MAA); drive continuous improvement and inspection readiness; mentor QC team. Requirements: BS/BA, MS, or PhD in Analytical Sciences or related field; 15+ years in QC with significant leadership in late-stage development and commercial manufacturing; deep knowledge of GMP, ICH guidelines, data integrity, and analytical method validation; experience with global regulatory submissions. HighValue: biologics/oligonucleotide modalities, haploinsufficiency CNS/eye indications, GMP/QMS expertise, regulatory interface, leadership in QC lifecycle management, global compliance, 20% travel. WorkSetup: hybrid in Bedford, MA, relocating to Waltham, MA by 2026.