Associate Director, Quality Assurance, GMP

Who We Are:


Xenon Pharmaceuticals (NASDAQ: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 to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, we announced the completion of patient enrollment in our Phase 3 X-TOLE2 study, and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. We have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in 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, Quality Assurance, GMP to join our team. The Associate Director, Quality Assurance, GMP will work collaboratively with multidisciplinary teams and ensure adherence to GMP regulations and regulatory requirements in support of Xenon’s late-stage clinical development programs and NDA preparation.
This position reports to the Director, Quality Assurance, GMP, and will be based out of the Boston, MA, USA location; we may consider other locations for an exceptional candidate. The level of the position will be commensurate with the candidate’s education and industry experience. For local candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
• Contribute to the management of Xenon’s quality systems and activities including change control, nonconformance and deviation management, complaint and recall management, quality risk management, vendor qualification, audits, GxP training programs, data quality audits, and inspection readiness.
• Compile and evaluate quality metrics and trends for timely identification, resolution, and communication of compliance risks and to foster continual process improvement initiatives.
• Manage batch release operations activities, including but not limited to master and executed batch record review, deviations, investigations, change controls and CAPAs review, and analytical data review.
• Lead and manage critical activities and milestones of the CDMO life cycle: qualification and selection, technology transfer, management, and decommission.
• Facilitate and resolve quality issues with CDMOs and internal stakeholders; ensure that products meet all required quality standards and specifications.
• Maintain CDMO site readiness for Health Authority regulatory inspections.
• Apply risk-based review processes for GMP documentation by identifying key elements such as critical quality attributes, critical process parameters, and critical material attributes suitable for the phase of development.
• Contribute to training initiatives and GMP compliance interpretation to support and improve quality processes that assure product quality and data integrity.
• Participate in on-site regulatory inspections and Xenon audits.
• Establish and maintain effective working relationships that promotes continuous application of quality principles and compliance with regulatory requirements while remaining independent. Develop strong working relationships with CMC, Quality Control, and Regulatory functions.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some domestic and/or international travel may be required.
• Other duties as assigned.
QUALIFICATIONS:
• Bachelor’