Associate Director, Quality Control

Role: Associate Director of Quality Control overseeing clinical and commercial drug substance and drug product testing for small molecule programs in accordance with ICH and cGMP standards. Responsibilities: manage master specifications, lead stability activities, investigate OOS/OOT results, review analytical data, oversee reference standards, support regulatory submissions, and coordinate with external labs and CMOs. Lead internal team performance, ensure compliance with quality systems, and support tech transfers from discovery to development. Requirements: undergraduate degree in life sciences, 8+ years in pharma with management experience in small molecules or biologics; strong QC testing, stability management, and regulatory submission knowledge; experience auditing labs and working in global regulatory environments (FDA, EMA). Preferred: experience with IND/BLA/CTA filings, inspection readiness, and cross-functional collaboration in CMC. High-value: extensive QC and stability expertise, support for late-stage clinical programs including Phase 3, regulatory documentation, and international travel (~20%). Work setup: Boston-based with hybrid options; some international travel expected.