Xenon Pharmaceuticals
Biotech
Director,QualityAssurance,GCP
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Quality Assurance, GCP at Xenon Pharmaceuticals. Skills: Quality Assurance, GCP, GLP. Lead quality oversight of GLP programs. Manage GLP audit program”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Clinical/non-clinical quality background, 5+ years management experience, GLP/GCP/GVP regulations knowledge, Drug development process understanding, Audit experience, CAPA experience, Risk evaluation experience, Strategic thinking ability, Organizational skills, Project team driving ability, Hands on work willingness, Professional communication, Clear communication, Concise communication, Consistent communication, Independent work ability, Collaborative work ability, People management skills, Mentorship skills, Negotiation skills, Conflict resolution skills
Nice to Have
Experience interacting with regulatory inspectorates
What You'll Do.
Lead quality oversight of GLP programs
Manage GLP audit program
Develop annual GLP audit plan
Lead quality oversight of early phase clinical programs
Provide GLP/GCP compliance interpretation
Provide GLP/GCP consultation
Provide GLP/GCP training
Provide root cause analysis
Identify critical quality issues
Escalate critical quality issues
Assist with regulatory inspection preparation
Coordinate regulatory inspections
Maintain cross-functional communications
Collaborate on quality principles
Collaborate on regulatory requirements
Ensure compliance with legislation
Ensure compliance with regulations
Develop GLP/GCP objectives
Propose GLP/GCP objectives
Plan budget proposals
Manage approved budgets
Recruit direct reports
Direct direct reports
Develop direct reports
Evaluate direct reports
How You'll Work.
Team & Collaboration
Cross-functional communications; Internal stakeholders; External stakeholders; Multidisciplinary team
Communication Scope
Interpersonal skills; Excellent communication; Verbal communication; Written communication
Process & Methodology
Project teams, Critical milestones, Timelines, Budgets
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
Applying for this Director, Quality Assurance, GCP role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Ashby
- Ashby is a fast modern ATS — most applications take under 3 minutes.
- The resume parser is strong; verify parsed experience dates and job titles.
- Custom screening questions are often scored algorithmically — answer completely.
- Location field affects geo-based screening; use your actual metro area.
ANONYMOUS · UNFILTERED
What do employees actually say about Xenon Pharmaceuticals?
Real rants from real employees. Read before you apply.