Associate Director, Quality Control

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 190,000 - 230,000; Full time

Benefits offered by this job

Base salary plus bonus

Stock options

Medical, dental, vision

Short- and long-term disability

AD&D and life insurance

Employee Assistance Program

Travel insurance

Retirement savings program

Job summary

Xenon Pharmaceuticals invites an experienced Associate Director to lead Quality Control activities across DS/DP programs in line with ICH and cGMP. The role requires managing analytical testing, stability programs, investigations, and collaboration with QA and external labs.

The position is based in Boston, MA, with remote options for exceptional candidates and a hybrid schedule requiring two onsite days weekly.

Qualifications

• Undergraduate life sciences degree with 8+ years of management experience.
• Experience auditing external labs and FDA/EMA inspections preferred.
• Strong QC testing and stability program management per ICH.
• Experience with IND/BLA/CTA CMC submissions preferred; cGMP knowledge.
• Excellent communication and prior teams leadership.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Lead master specifications for starting materials, reference standards, API, and drug products for assigned programs.
• Lead stability activities including data trending, evaluation, and expiry dating justifications.
• Manage stability studies and reference standards with tracking of shelf-life extensions.
• Lead investigations and draft reports for OOS/OOT results during release and stability testing.
• Review and manage all analytical results for release and stability, organize QC data.
• Coordinate reference standard program with external labs, CMOs, and testing facilities.
• Lead QA collaborations on regulatory submissions (IND, CTA, NDA) and transfer protocols.
• Oversee internal release documents for drug substances/products and reference standards.
• Ensure compliance with audits by external labs and CMOs, and participate in remote/on-site audits.
• Support collaboration between Drug Product and API groups for trial material readiness.
• Provide QC knowledge to transfer candidates from discovery to CMC teams.
• Oversee sample movement between labs and CMOs for testing and releases.
• Manage team capacity and performance reviews, plus other duties as needed.

Skills

Quality Control

Project Management

Leadership

Regulatory Knowledge

Cross-functional Collaboration

Communication

Travel Willingness

Education

Bachelor's in Life Sciences

Job description

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 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 Boston, MA, USA in our Needham office. 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 with quality assurance.
• Ensure effective working relationships with external laboratories and CMOs, participate in remote audits, and perform on-site audits as required.
• Effectively collaborate with colleagues in Drug Product and API groups, such that deliverables are optimal for use in clinical trial material.
• Provide technical knowledge of quality control to support the transfer of new drug candidates from research/discovery groups to the CMC drug development team.
• Oversee the movement of samples between external testing partners and CMOs for tech transfers, release, and stability testing of assigned program(s).
• Assess team capacity and lead the assigned team to ensure project deliverables are met, including management of performance reviews. Other duties as required from time to time.
• Engage in and ensure compliance with appropriate quality functions, including deviations, change controls, and CAPAs.
• May 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

• An undergraduate degree in life sciences, with 8+ years 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 is required.
• Prior experience with IND, BLA, 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.