Senior Manager/Associate Director, Quality Assurance, GCP

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 Manager/Associate Director, Quality Assurance, GCPto join our team. We are building our Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This person will provide Quality support primarily in support of early-stage clinical programs (pre-phase 3). This position will support inspection readiness initiatives to ensure compliance within the R&D Program. The successful candidate must have a solid Clinical Quality background, including providing Quality support for study teams, auditing, and inspections. The ideal candidate will be someone who is data-driven and focused on the science of early phase clinical development. Experience in GLP regulations is a plus. This position must have proven interpersonal skills, excellent communication skills, and a collaborative and pragmatic approach to Quality. This position reports to the Director, Quality Assurance, GCP and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. 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:** - Serve as the quality representative for assigned early phase clinical programs to include activities such as development and maintenance of Quality Plans, facilitation of study quality risk assessments and oversight of Critical to Quality Factors and Quality Tolerance Limits. - Support quality oversight of GLP programs, including the audit program activities, collaborating with Quality Systems to support development of the annual audit plan. - Provide GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated. - Identify and escalate critical quality issues appropriately to QA Management. - Assist with the preparation and support of regulatory inspections held remotely and onsite at the Company’s offices, clinical trial sites, and contract service provider facilities, as needed. - Maintain respectful, inclusive, and effective cross-functional communications, collaborating with internal and external stakeholders on strategy and implementation of quality principles and regulatory requirements while remaining independent. - Support short- and long-term objectives for the GLP/GCP functions in accordance with overall Company and Quality strategies. - 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. - Other duties as assigned. **QUALIFICATIONS:** - Bachelor’s degree in a scientific or health field with at least 8 years of GxP QA experience, 6+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry. - A minimum of 3 years in a quality lead role in a pharma or biotech environment. Job level commensurate with years of experience. - Extensive knowledge of GCP regulations, guidelines, current industry trends, standards, and methodologies. - Sound knowledge of GLP regulations, guidelines, current industry trends, standards, and methodologies. - Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable. - Strong understanding of all phases of the drug development process and the interdependencies with other functional areas, but experience in early phase (pre-phase 3) is required. - Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks. - Ability to effectively prioritize and manage multiple complex projects in parallel and successfully achieve critical milestones and expected deliverables within established timelines and budgets. - Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do the work to achieve goals. - Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders. - Proven ability to work independently and collaboratively as part of a multidisciplinary team. 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.