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Associate Director, Quality Assurance, GMP

Xenon

Job Overview

Location

Remote

Job Type

Full-time

Full Job Description

📋 Description

• Xenon Pharmaceuticals is a dynamic, neuroscience-focused biopharmaceutical company at the forefront of drug discovery, clinical development, and commercialization, dedicated to creating life-changing therapeutics for patients with significant unmet medical needs. We are driven by a mission to advance innovative treatments for conditions such as epilepsy and depression, leveraging our deep expertise in ion channel modulation. Our commitment to scientific excellence and patient well-being is matched by our dedication to fostering a respectful, collaborative, inclusive, and productive work environment where great people can thrive.
• As an Associate Director, Quality Assurance, GMP, you will play a pivotal role in ensuring the highest standards of quality and compliance across our late-stage clinical development programs and in preparation for our New Drug Application (NDA). This remote position, reporting to the Director, Quality Assurance, GMP, offers a unique opportunity to contribute to the success of groundbreaking neuroscience therapies. While based out of Vancouver, BC, Canada, we are open to considering remote candidates located in Ontario or Quebec. The specific level of the position will be determined based on your educational background and extensive industry experience.
• You will be instrumental in managing and enhancing Xenon's robust quality systems. This includes overseeing critical processes such as change control, nonconformance and deviation management, complaint and recall procedures, quality risk management, vendor qualification, and the execution of comprehensive GxP training programs. Your responsibilities will extend to conducting data quality audits and ensuring our readiness for regulatory inspections, thereby safeguarding product integrity and patient safety.
• A key aspect of this role involves the meticulous compilation and evaluation of quality metrics and trends. By proactively identifying and analyzing these trends, you will contribute to the timely resolution of compliance risks, facilitate effective communication across teams, and champion initiatives for continual process improvement. Your insights will be crucial in maintaining and elevating our quality standards.
• You will directly manage batch release operations, a critical function that ensures the quality and compliance of our manufactured products. This includes the thorough review of master and executed batch records, the investigation of deviations, the assessment of change controls and CAPAs (Corrective and Preventive Actions), and the rigorous review of analytical data. Your diligence in these areas is paramount to the successful progression of our drug candidates.
• This position requires significant leadership in managing the entire lifecycle of our Contract Development and Manufacturing Organizations (CDMOs). This encompasses their qualification and selection, the seamless execution of technology transfers, ongoing management, and eventual decommissioning. You will be the primary point of contact for facilitating and resolving quality issues with CDMOs and internal stakeholders, ensuring that all products consistently meet required quality standards and specifications.
• Maintaining CDMO site readiness for Health Authority regulatory inspections is a core responsibility. You will apply a risk-based review process to all GMP documentation, meticulously identifying critical quality attributes (CQAs), critical process parameters (CPPs), and critical material attributes (CMAs) relevant to the current phase of development. This proactive approach ensures compliance and minimizes potential risks.
• You will contribute significantly to training initiatives and provide expert interpretation of GMP compliance requirements. Your efforts will support and improve quality processes, ensuring the highest levels of product quality and data integrity. This includes actively participating in on-site regulatory inspections and Xenon's internal audits, representing the company with professionalism and expertise.
• Establishing and maintaining effective working relationships is essential. You will foster an environment that promotes the continuous application of quality principles and strict adherence to regulatory requirements, while maintaining the necessary independence expected of a Quality Assurance function. Building strong collaborative relationships with CMC (Chemistry, Manufacturing, and Controls), Quality Control, and Regulatory Affairs functions will be key to your success.
• You are expected to act in accordance with all Company policies, including the Code of Business Conduct and Ethics, and ensure these policies are understood and followed by any direct reports. Some domestic and international travel may be required to support our global operations. Other duties as assigned will ensure you are a versatile and integral member of the team.

🎯 Requirements

• Bachelor's degree in a life science discipline, coupled with approximately 8 years of progressive management and Quality Assurance experience, or a comparable background of relevant QA experience within the drug development sector of the bio-tech or pharmaceutical industry.
• Profound knowledge and hands-on experience with global GMP regulations, principles, and guidelines, alongside a strong understanding of current industry standards, best practices, and methodologies.
• Solid comprehension of the drug development process, including Process Performance Qualification (PPQ), and the critical interdependencies between Quality Assurance and other functional areas such as CMC, Clinical Operations, and Regulatory Affairs.
• Demonstrated ability to work autonomously and collaboratively within multidisciplinary teams, effectively prioritizing and managing complex projects within established timelines, showcasing strong critical thinking and decision-making skills.
• Excellent written and oral communication skills, ensuring clear, concise, and professional interactions with internal and external stakeholders.

🏖️ Benefits

• Comprehensive Total Rewards program including competitive base salary, target bonus, and stock options.
• Extensive health and wellness coverage: medical, dental, vision, short-term and long-term disability, accidental death & dismemberment, and life insurance programs.
• Robust retirement savings programs with company matching contributions.
• Generous paid time off: vacation, personal days, sick days, and an end-of-year company shutdown to encourage rest and rejuvenation.
• Commitment to professional growth: expanding Training, Learning & Development program, including Tuition Assistance for advanced degrees.

Skills & Technologies

REST

Junior

Remote

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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