Xenon Pharmaceuticals

Biotech

Director,QualityAssurance,GMP

CA$178–196k Vancouver, British Columbia, Canada; Boston, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Director, Quality Assurance, GMP at Xenon Pharmaceuticals. Skills: Quality Assurance, GMP, Clinical programs. Manage quality matters for CMO manufacturing. Manage quality matters for CMO testing”

Industry & Context.

Biotech
Problems you'll solve

Troubleshoot; Resolve problems

What They're Looking For.

Must Have

10+ years GMP quality leadership, Life sciences degree, Small molecule manufacturing experience, Early phase drug development experience, Global GxP expectations knowledge, QP requirements knowledge, Organize and multitask ability, Establish quality system metrics, Establish process indicators, Interpersonal skills, Lead cross functional projects, Work with suppliers and CMOs, Communicate proactively, Communicate solution-focused, Keep management aware, Communicate issues with CMOs, Goal oriented, Troubleshoot and resolve problems, Continuous improvement champion, Work with minimal supervision, Set priorities to meet timelines, Motivate and influence others, Team building skills, Managing skills

Nice to Have

Experience with small virtual company

What You'll Do.

Manage quality matters for CMO manufacturing

Manage quality matters for CMO testing

Manage quality matters for CMO release

Lead external quality activities

Support external quality activities

Collaborate with internal CMC functions

Align goals for clinical programs

Align objectives for clinical programs

Ensure cGMP compliance

Realize value-added policies

Realize best practices

Author quality documents

Review quality documents

Approve quality documents

Attend internal CMC team meetings

Provide quality feedback

Collaborate on complex investigations

Support quality system review meetings

Support product review meetings

Provide data for quality metrics

Provide quality reviews for CMC documents

Provide quality reviews for health authority documents

Review data for compliance

Verify data for compliance

Represent Quality on project teams

Represent Quality at Health Authority Inspections

Represent Quality at supplier meetings

Represent Quality at CMO operational meetings

Represent Quality at QA to QA meetings

Promote quality mindset

Promote quality excellence approach

Recruit direct reports

Direct direct reports

Develop direct reports

Evaluate direct reports

How You'll Work.

Team & Collaboration

R&D Operations group; Internal CMC functions; Cross-functional projects; External advisors; External partners; Project teams; Health Authority Inspections; Suppliers; CMO operational meetings; QA to QA meetings

Communication Scope

Proactive communication; Solution-focused communication; Communicate issues

Full 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 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neur

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