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.