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, 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, 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 Vancouver, BC, Canada. Remote candidates based in Ontario or Quebec may be considered. 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.

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’s degree in life sciences with approx. 8+ years of management and Quality Assurance experience, or comparable background of relevant QA experience in drug development in the bio-tech or pharmaceutical industry.

• Strong knowledge and experience with global GMP regulations, principles and guidelines, current industry standards, best practices, and methodologies.

• Good understanding of the drug development process, including PPQ and the interdependencies between QA and other functional areas. Previous experience with drug substance or drug product manufacturing is highly desirable.

• Strong critical thinking and decision-making skills.

• Organizational skills and attention to detail to effectively prioritize and manage complex projects within established timelines.

• Proficient in conducting quality audits and collaborating with auditees to develop CAPA plans, addressing root causes and mitigating risks.

• Ability to work autonomously and collaboratively as part of a multidisciplinary team.

• Clear, concise, and professional written and oral communication skills.

• Experience maintaining an electronic quality management system is beneficial.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.