Xenon Pharmaceuticals
Biotech
Director,QualityAssurance,GMP
Neural analysis suggests this role is
optimal for Director candidates.
“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.
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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