Director, Quality Assurance, GMP

Xenon

Job Overview

Location

Vancouver

Job Type

Full-time

Full Job Description

📋 Description

• Lead quality assurance activities for clinical-stage small molecule products manufactured by Contract Manufacturing Organizations (CMOs), ensuring full compliance with cGMP regulations and global GxP standards.
• Oversee batch review and release processes for clinical materials, including analytical method validations, tech transfers, deviations, and quality agreements with external suppliers and CMOs.
• Author, review, and approve critical quality documents such as quality agreements, disposition records, audit reports, and quality system documentation.
• Collaborate closely with internal CMC, Regulatory, Supply Chain, and Program Management teams to align quality strategies with clinical development goals for Xenon’s pipeline, including azetukalner and early-stage candidates like XEN1701 and XEN1120.
• Represent the Quality function on cross-functional project teams, health authority inspections, supplier meetings, and QA-to-QA discussions with external partners.
• Conduct and support supplier and CMO audits, monitor performance, and ensure ongoing compliance with quality expectations and contractual obligations.
• Establish, track, and report key quality system metrics and process indicators to proactively identify trends, mitigate risks, and drive continuous improvement in quality operations.
• Review and verify data integrity across CMC and regulatory submissions to ensure compliance with FDA and international regulatory requirements.
• Provide quality input and oversight for health authority submissions, including New Drug Applications (NDAs) and regulatory documents related to Phase 3 epilepsy and depression programs.
• Lead, recruit, coach, and evaluate direct reports in accordance with company HR policies, fostering a culture of quality excellence and accountability.
• Ensure adherence to Xenon’s Code of Business Conduct and Ethics, and promote a company-wide quality mindset across all levels of the organization.
• Participate in internal quality system and product review meetings, delivering data-driven insights and recommendations to senior leadership.
• Engage in international travel as needed for CMO audits, regulatory inspections, and cross-functional collaboration.
• Act as a key liaison between Xenon and external manufacturing partners, resolving complex quality issues with a proactive, solution-focused approach.
• Support the transition of clinical-stage products toward commercial readiness by implementing scalable quality systems and best practices.
• Maintain up-to-date knowledge of evolving global regulatory expectations, including Qualified Person (QP) requirements and regional GMP standards.
• Contribute to the development and enhancement of Xenon’s quality policies, procedures, and training programs to support growth and compliance.
• Ensure all quality activities align with the company’s strategic objectives in neuroscience drug development, including epilepsy, depression, and pain indications.

🎯 Requirements

• Bachelor’s degree in a life sciences discipline with 10+ years of experience in GMP quality leadership roles
• Strong understanding of small molecule manufacturing, including drug substance and solid oral dosage product production and distribution
• Extensive experience with early-phase clinical development and global GxP regulations, including QP requirements
• Proven track record leading quality functions in a small virtual biopharmaceutical company
• Demonstrated ability to manage CMOs and external suppliers through audits, quality agreements, and performance monitoring
• Strong interpersonal and communication skills with experience leading cross-functional teams and influencing stakeholders at all levels

🏖️ Benefits

• Base salary, target bonus, and stock options
• Comprehensive medical, dental, and vision insurance
• Short- and long-term disability, accidental death & dismemberment, and life insurance
• Employee Assistance Program and travel insurance
• Retirement savings program with company matching contributions
• Paid vacation, personal days, sick days, and end-of-year company shutdown
• Tuition Assistance program for advanced degrees
• Expanding Training, Learning & Development program

Skills & Technologies

REST

Hybrid

Degree Required

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Xenon

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About Xenon

Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.

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