Senior Director, Quality Assurance, Commercial

Job description

***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. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for 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 a **Senior Director, Quality Assurance, Commercial** as an integral leader within the Quality GMP team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory Affairs, Supply Chain and Quality functions. Leveraging an extensive background in Quality and all manufacturing stages (Drug Substance, Drug Product, Finished Goods) of products for commercial distribution will ensure the Quality program requirements are met. The successful candidate will have proven leadership ability in a fast-paced and complex environment, and will interact with all levels of internal staff, as well as with external advisors and partners. This position reports to the Executive Director, Quality Assurance, GMP and will be based out of Boston, MA, USA in our Needham office. We may consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office. **RESPONSIBILITIES:** · Lead and manage key activities related to commercial manufacturing, testing and disposition of product at CMOs in accordance with regulatory and internal requirements. This includes, but not limited to, batch reviews and release, tech transfers and validations, deviations, quality agreements, and supplier qualifications including auditing and monitoring. · Effectively lead and manage a global team to ensure functional and program objectives are met · Collaborate and partner with leaders within the CMC and Supply Chain organization to ensure key objectives for commercial programs and small molecule products; ensure cGMP compliance and realization of value-added policies and best practices. · Recommend and implement strategic system improvements for commercial Quality requirements such as CPV, APR, KPI metrics, as required. · Attend CMO and internal CMC team meetings; provide feedback and collaborate on complex investigations. Escalate or advise key topics, as required. · Support the Quality Systems team and contribute to product review meetings; present Quality metrics (internal and vendor metrics). Provide timely reports and reviews of key CMC and health authority documents. · Represent the Quality function as a trusted advisor on product development teams (PDTs), Health Authority Inspections, for suppliers and at CMO operational meetings, including “QA to QA” meetings. · Promote a Quality and patient-first mindset and inspire Quality excellence throughout to the organization. · Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices. · 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 international travel may be required. · Other duties as assigned. **QUALIFICATIONS:** · Bachelor’s degree in a life sciences discipline, with 12+ years of relevant management experience in GMP quality leadership positions; an advanced degree is preferred. · Strong understanding of small molecule manufacturing including drug substance manufacture, drug product manufacture with direct experience in solid oral dosage and finished goods production and distribution. Must have experience with virtual manufacturing partners. · Extensive GxP knowledge with commercial production/disposition experience. · Strong knowledge of global GxP expectations and QP (Qualified Person) requirements. · Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment. · Extensive experience establishing key quality system metrics and process indicators to proactively identify and address quality systems or product issues. · Strong interpersonal skills, with experience in leading cross functional projects including a successful track record working with suppliers and CMOs. · Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CMOs. · Goal oriented with the ability to troubleshoot and resolve problems. · Be a champion for continuous improvement in all aspects of total quality management. · Ability to work independently to set priorities to meet timelines · Previous experience leading and managing on-site and remote employees. 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.