Associate Director, Quality Control

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. 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 an experienced Associate Director to lead Quality Control activities supporting clinical and commercial drug substance (DS) and drug product (DP) programs in accordance with ICH and cGMP requirements. The ideal candidate will have a strong background in small molecules, with experience spanning early to late clinical phases through registration, PPQ, and commercial stages. This role requires expertise in managing analytical testing, specifications, stability program, reference standards, investigations, and quality control oversight across DS and DP manufacturing and testing campaigns. The ideal candidate will be collaborative, science and data driven, and thrive working in a fast-paced environment. This position reports to the Director, Quality Control and will be based out of Vancouver, BC, Canada. We will consider remote locations for exceptional candidates. Hybrid positions require a minimum of two onsite days per week. RESPONSIBILITIES:

Manage master specifications for starting materials, reference standards, API, and drug products for assigned clinical/commercial program(s).

Lead the assigned program’s stability activities, including trending, statistical evaluation, and scientific interpretation of stability data to assess product performance throughout its lifecycle, support shelf-life extensions and expiry dating justifications, and proactively identify and evaluate emerging stability risks and trends.

Manage stability studies for reference standards, API, and drug products for assigned programs. Compile stability protocols and monitor all stability data, including shelf-life trending and extensions.

Lead investigations and draft reports for out-of-specification (OOS) and out-of-trend (OOT) results during release and stability testing in close collaboration with internal teams and external testing labs.

Review, manage all analytical/non-analytical results for product release, and stability, including OOS and OOT observations. Organize and file internal and external quality control data, protocols, and reports.

Manage the reference standard program for the assigned clinical/commercial program at dedicated external labs, including qualification and distribution of reference standards to all manufacturing & testing facilities.

Lead quality control checks on the CMC sections of regulatory submissions (e.g., Investigational New Drugs (INDs), Clinical Trial Applications (CTAs), and New Drug Applications (NDAs).

Manage the review and approval workflow for feasibility/comparability studies, validation protocols, reports, and test methods with internal experts and external partners.

In collaboration with QA, manage internal release documents for drug substances, drug products, and reference standards, including Certificate of Analysis and Certificate of Testing in collaboration wit