Executive 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 flagship 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 August 2025, we announced the completement of patient recruitment 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, and 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 Executive Director, Quality Assurance, GMP to join our team. This Executive Director, Quality Assurance, GMP will be an integral member of the Quality leadership team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory, and Quality functions. Leveraging an extensive background in quality and manufacturing in all clinical phases through to commercial, will ensure the quality program requirements are met.
The Executive Director, Quality Assurance, GMP will have proven leadership ability in a fast-paced and complex environment, and will interact with all levels of internal staff, as well as external advisors and partners.
This position reports to the Senior Vice President, Quality Assurance and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office
RESPONSIBILITIES:
• Responsible for all quality-related matters related to manufacturing, testing and release at a CMO (Contract Manufacturing Organization); act as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and controls.
• Lead and support activities related to external quality such as, but not limited to, batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications including auditing and monitoring.
• Collaborate with internal CMC functions and aligns goals and objectives from clinical to commercial phase programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
• Ensure quality policies and objectives are understood, implemented, and maintained for all applicable GMP roles. Identifies gaps and provides solutions for new processes and documents to ensure readiness for inspections and audits.
• Author and review or approve quality documents including quality agreements, certificates of release, and audit reports.
• Attend CMO and internal CMC team meetings and provide quality feedback supporting Xenon products including collaborations on complex investigations.
• Attend and support quality system and product review meetings including providing data for quality metrics (internal and vendor metrics). Provide quality reviews of key CMC and health authority documents. Review and verify data to assure compliance with data integrity.
• Represent Quality function on project teams, Health Authority Inspections, suppliers and CMO operational meeting