Senior Manager/Associate Director, Quality Control

Role: Senior Manager/Associate Director of Quality Control overseeing analytical testing for clinical and commercial drug substances and products, ensuring compliance with ICH and cGMP standards. Responsibilities: manage testing results, stability programs, reference standards, specifications, investigations, and QC oversight across manufacturing stages; lead stability assessments and trending; coordinate with external labs and CMOs; support regulatory submissions (IND, NDA, CTA) QC documentation; facilitate tech transfers and compliance audits; lead or supervise QC team if applicable; ensure adherence to quality policies, and may participate in international audits and travel. Requirements: 5+ years (Senior Manager) or 8+ years (Associate Director) experience in pharmaceutical QC, preferably within small molecules or biologics, with proven expertise in stability management, QC testing, investigations, and regulatory documentation; strong knowledge of ICH guidelines, cGMP, and global regulatory standards; experience with external labs, audits, and cross-functional collaboration; excellent communication skills. HighValue: small molecule/biologics, clinical and commercial stages, IND/NDA submissions, stability and specifications management, cGMP, international regulatory environment. WorkSetup: hybrid or onsite Vancouver, BC or Boston, MA; up to 20% travel.