Senior Manager/Associate Director, Quality Control

The posting, as Xenon Pharmaceuticals wrote it

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 submitted 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 Senior Manager/Associate Director, Quality Control 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 Boston, MA, USA in our Needham offi
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ts, if any.

• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS

• An undergraduate degree in life sciences, with 5+ years (Senior Manager level) or 8+ years (Associate Director level) of relevant management experience in the pharmaceutical industry (small molecules and/or biologics).
• Previous experience working with external testing laboratories; independently and influences in a fast-paced environment, while exhibiting a strong quality mindset.
• Comfortable working across locations and time zones.
• Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness is preferred.
• Strong experience with quality control testing, stability program management in accordance with ICH guidelines, master specifications, method validations, investigations (OOS/OOT), batch release processes, and quality management systems are required.
• Prior experience with IND, NDA and/or CTA CMC submissions is preferred; knowledge of cGMP and the US, Canadian, and EU regulatory environments.
• Collaboration and inclusion between external testing labs and cross-functional CMC teams are essential.
• Excellent oral and written communication skills and previous team leadership experience.
• Willingness to travel up to 20% of the time domestically and internationally.

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.