Associate Director/Director, Quality Assurance, GCP

Associate Director/Director, Quality Assurance, GCP Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/xene) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting, and continue to advance an early-stage pipeline of novel therapeutic candidates. In 2025, we initiated Phase 1 trials for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7). Nav1.7 and Kv7 are important pain targets, and data from these Phase 1 studies are expected in 2026 to support Phase 2 proof-of-concept studies in acute pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking an Associate Director/Director, Quality Assurance, GCP to join our team. We are building the GCP Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This position will contribute to inspection readiness initiatives and for ensuring compliance within R&D Programs. This position reports to the Executive Director, Quality Assurance, GCP and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. RESPONSIBILITIES: - Ensure the Company’s quality systems and activities are actively managed to include, but not limited to quality risk management, inspection readiness, quality issue management, data quality auditing, and GLP/GCP training. - Manage internal and external GLP/GCP audit programs and activities, collaborating with key stakeholders to ensure quality compliance for current and future programs. - Provide GLP/GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to ensure the protection of study participants’ safety and rights and the quality, integrity, and credibility of data generated. - Identify and escalate critical quality issues appropriately to QA Management; support investigations as required. - Collaborate with internal departments to implement quality principles and regulatory requirements whil ... (truncated, view full listing at source)