Senior Manager​/Associate Director, Quality Assurance, GCP

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.

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. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN
1701 and XEN
1720 (targeting Nav
1.7) and XEN
1120 (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.

We are seeking a Senior Manager/Associate Director, Quality Assurance, GCP to 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.

• 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 escalation 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…