Senior Director, Quality Assurance, Commercial

Role: Senior Director, Quality Assurance, Commercial at Xenon Pharmaceuticals, overseeing quality activities for commercial manufacturing of small molecule therapeutics, primarily in neuroscience indications such as epilepsy and depression. Responsibilities: lead manufacturing, testing, batch review, supplier qualification, and validation at CMOs; manage a global team; collaborate across R&D, CMC, supply chain; implement quality system improvements; represent QA in regulatory and supplier audits; promote a quality-first culture. Requirements: Bachelor’s in life sciences; 12+ years GMP quality leadership experience; deep knowledge of small molecule manufacturing, GxP standards, and global QP requirements; proven leadership in complex, fast-paced environments; experience with virtual manufacturing partnerships; strong cross-functional and communication skills. HighValue: expertise in small molecule drug substance and finished goods production, commercial distribution, and cGMP compliance; experience with regulatory inspections and quality metrics; international travel may be required. WorkSetup: hybrid Boston, MA; some international travel.