Associate Director Director, Quality Assurance, GCP

📋 Description

• • Xenon Pharmaceuticals is a dynamic, neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing groundbreaking therapeutics for patients facing significant unmet medical needs. We are driven by a mission to improve lives through innovative science and a dedication to excellence. Our culture is built on respect, collaboration, inclusivity, and productivity, and we are seeking exceptional individuals who embody these values to join our growing team.
• • Our current pipeline is robust and exciting, targeting critical indications such as epilepsy and depression. A cornerstone of our development efforts is the Phase 3 azetukalner program, which represents the most advanced, clinically validated potassium channel modulator in late-stage development for multiple indications. Building on the positive outcomes and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our comprehensive Phase 3 epilepsy program encompasses multiple clinical trials designed to evaluate azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. We recently achieved a significant milestone with the completion of patient enrollment in our Phase 3 X-TOLE2 study in November 2025, and we eagerly anticipate the topline data in March 2026.
• • Beyond epilepsy, we are making substantial progress in major depressive disorder (MDD) and bipolar depression (BPD) with multiple Phase 3 azetukalner clinical trials currently underway. These trials are informed by the promising topline data from our Phase 2 X-NOVA clinical trial, further underscoring the potential of azetukalner across a spectrum of neurological conditions.
• • Our commitment to innovation extends to our discovery labs, where we are leveraging our deep expertise in ion channels and advanced drug discovery capabilities. This has led to the initiation of early-stage research programs focused on identifying validated drug targets and developing novel product candidates. We are proud to have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, which is being investigated for pain indications.
• • Xenon is strategically positioned for sustained growth, supported by a strong financial foundation. We are dedicated to building a fully integrated, premier neuroscience company with robust capabilities spanning discovery, clinical development, corporate functions, and commercial operations.
• • We are actively seeking an Associate Director, Quality Assurance, GCP to join our expanding Quality Assurance team. This pivotal role will be instrumental in establishing and maturing the GCP Quality function, providing critical support for Xenon's clinical development programs. You will play a key role in driving quality initiatives across the organization, ensuring inspection readiness, and upholding compliance within our Research & Development programs. This position reports directly to the Executive Director, Quality Assurance, GCP.
• • Key responsibilities will include the proactive management of the Company's quality systems and activities. This encompasses crucial areas such as quality risk management, ensuring robust inspection readiness, effective quality issue management, diligent data quality auditing, and comprehensive GLP/GCP training programs. You will be responsible for managing internal and external GLP/GCP audit programs and activities, fostering strong collaborations with key stakeholders to guarantee quality compliance for both current and future programs.
• • You will serve as a primary resource for GLP/GCP compliance interpretation, consultation, and training, providing essential support to maintain and enhance the quality of Xenon's R&D programs. Your efforts will directly contribute to safeguarding the safety and rights of study participants and ensuring the utmost quality, integrity, and credibility of the data generated.
• • A critical aspect of this role involves identifying and escalating significant quality issues to QA Management, while also actively supporting investigations as needed. You will collaborate closely with various internal departments to embed quality principles and regulatory requirements into our operations, maintaining a crucial independent oversight.
• • You will lead and manage GLP/GCP inspection readiness activities, preparing the organization for pre-approval inspections. Depending on business needs, you may also contribute to Good Vigilance Practices (GVP) activities. Your involvement may extend to participating in regulatory inspections at the Company's offices, clinical study sites, and contract service provider facilities.
• • If applicable, you will have the opportunity to recruit, lead, direct, develop, coach, and evaluate direct reports, ensuring adherence to Xenon's Human Resource policies and practices. You will act in accordance with all Company policies, including the Code of Business Conduct and Ethics, and ensure these are understood and followed by your team.
• • This role may require some international travel. Other duties as assigned will ensure a dynamic and varied work experience.