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-related matters for manufacturing. Manage quality-related matters for testing”
Industry & Context.
Troubleshoot problems; Resolve problems
What They're Looking For.
Must Have
10+ years of experience in GMP quality leadership, Degree in a life sciences discipline, Experience with small molecule manufacturing, Experience in solid oral dosage, Experience in finished goods production, Experience in distribution, Extensive GxP knowledge, Early phase drug development experience, Experience with a small virtual company, Ability to effectively organize, multitask, Ability to work in a fast-paced, deadline driven work environment, Extensive experience establishing key quality system metrics, Extensive experience establishing process indicators, Interpersonal skills, Ability to communicate in a proactive and solution-focused manner, Ability to communicate issues with CMOs, Goal oriented, Ability to troubleshoot and resolve problems, Ability to work with minimal supervision, Ability to set priorities to meet timelines, Ability to motivate and influence others, Team building skills, Managing skills
Nice to Have
Experience with global GxP expectations, Experience with QP requirements, Experience in leading cross functional projects, Successful track record working with suppliers, Successful track record working with CMOs, Recruiting skills, Coaching skills, Counseling skills, Disciplining skills
What You'll Do.
Manage quality-related matters for manufacturing
Manage quality-related matters for testing
Manage quality-related matters for release at CMO
Lead activities related to external quality
Support activities related to external quality
Perform batch reviews
Perform batch release
Perform analytical method validations
Perform tech transfers
Manage quality agreements
Manage supplier qualifications
Collaborate with internal CMC functions
Align goals and objectives for clinical phase programs
Align goals and objectives for small molecule products
Ensure cGMP compliance
Ensure realization of value-added policies
Ensure realization of best practices
Author quality documents
Review quality documents
Approve quality documents
Author quality agreements
Review quality agreements
Approve quality agreements
Author Quality systems documents
Review Quality systems documents
Approve Quality systems documents
Approve audit reports
Attend internal CMC team meetings
Provide quality feedback supporting Xenon products
Collaborate on complex investigations
Support quality system review meetings
Support product review meetings
Provide data for quality metrics
Provide data for internal metrics
Provide data for vendor metrics
Provide quality reviews of key CMC documents
Provide quality reviews of health authority documents
Review data to assure compliance
Verify data to assure compliance
Represent Quality function on project teams
Represent Quality function on Health Authority Inspections
Represent Quality function on suppliers meetings
Represent Quality function on CMO operational meetings
Represent Quality function on QA to QA meetings
Promote a quality mindset throughout the organization
Promote quality excellence approach throughout the organization
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; Working with suppliers; Working with CMOs
Communication Scope
Proactive communication; Solution-focused communication
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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