Xenon Pharmaceuticals Inc. · 3 weeks ago
Associate Director, Quality Assurance, GMP
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$160K/yr - $203K/yr
8+ years expXenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery and clinical development. The Associate Director, Quality Assurance, GMP will ensure adherence to GMP regulations and regulatory requirements in support of Xenon’s late-stage clinical development programs and NDA preparation.
BiopharmaBiotechnologyGeneticsHealth CareMedicalPharmaceutical
Responsibilities
Contribute to the management of Xenon’s quality systems and activities including change control, nonconformance and deviation management, complaint and recall management, quality risk management, vendor qualification, audits, GxP training programs, data quality audits, and inspection readiness
Compile and evaluate quality metrics and trends for timely identification, resolution, and communication of compliance risks and to foster continual process improvement initiatives
Manage batch release operations activities, including but not limited to master and executed batch record review, deviations, investigations, change controls and CAPAs review, and analytical data review
Lead and manage critical activities and milestones of the CDMO life cycle: qualification and selection, technology transfer, management, and decommission
Facilitate and resolve quality issues with CDMOs and internal stakeholders; ensure that products meet all required quality standards and specifications
Maintain CDMO site readiness for Health Authority regulatory inspections
Apply risk-based review processes for GMP documentation by identifying key elements such as critical quality attributes, critical process parameters, and critical material attributes suitable for the phase of development
Contribute to training initiatives and GMP compliance interpretation to support and improve quality processes that assure product quality and data integrity
Participate in on-site regulatory inspections and Xenon audits
Establish and maintain effective working relationships that promotes continuous application of quality principles and compliance with regulatory requirements while remaining independent. Develop strong working relationships with CMC, Quality Control, and Regulatory functions
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
Some domestic and/or international travel may be required
Other duties as assigned
Qualification
Required
Bachelor's degree in life sciences with approx. 8+ years of management and Quality Assurance experience, or comparable background of relevant QA experience in drug development in the bio-tech or pharmaceutical industry
Strong knowledge and experience with global GMP regulations, principles and guidelines, current industry standards, best practices, and methodologies
Good understanding of the drug development process, including PPQ and the interdependencies between QA and other functional areas. Previous experience with drug substance or drug product manufacturing is highly desirable
Strong critical thinking and decision-making skills
Organizational skills and attention to detail to effectively prioritize and manage complex projects within established timelines
Proficient in conducting quality audits and collaborating with auditees to develop CAPA plans, addressing root causes and mitigating risks
Ability to work autonomously and collaboratively as part of a multidisciplinary team
Clear, concise, and professional written and oral communication skills
Preferred
Experience maintaining an electronic quality management system is beneficial
Benefits
Medical
Dental
Vision
Short-& long-term disability
Accidental death & dismemberment
Life insurance programs
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Vacation
Personal days
Sick days
End-of-year company shutdown
Tuition Assistance program for advanced degrees
Company
Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.
201-500 employees
H1B Sponsorship
Xenon Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.29BKey Investors
Neurocrine Biosciences
2023-11-29Post Ipo Equity· $300M
2022-06-22Post Ipo Equity· $287.5M
2021-10-05Post Ipo Equity· $345M
Leadership Team
Ian Mortimer
President & CEO
Tucker Kelly
Chief Financial Officer
Recent News
2026-01-13
2025-12-05
2025-11-25
Company data provided by crunchbase