Director of Quality - GMP Biologics Clinical Trial Material Facility
Government of CanadaPriority may be given to the following designated employment equity groups: women, Indigenous Peoples* (First Nations, Inuit and Métis), persons with disabilities and racialized persons*. The Employment Equity Act , which is under review, uses the terminology Aboriginal peoples and visible minorities. Candidates are asked to self-declare when applying to this hiring process. City: Montréal Organizational Unit: Human Health Therapeutics Classification: MGT-2 Tenure: Term Language Requirements: Bilingual Imperative CBC/CBC Work arrangements: Due to the nature of the work and operational requirements, this position will require full-time physical presence at the NRC work location identified. At the NRC, we recognize that Indigenous candidates may have important connections to their communities and you may be eligible for an exception to this work arrangement. Alternative work arrangements may also be considered to accommodate candidates as required. To learn more about these options, please contact the NRC Hiring team using the contact information below. Discover the possible Anything is possible at the NRC, named in 2026 one of Canada’s Top Employers for Young People, Top Employer in the National Capital Region and Forbes Canada’s Best Employers! As Canada’s largest research and innovation organization, our world-renowned research pushes the boundaries of science and engineering to make the impossible, possible. Every day we explore new ideas through innovative research and help companies discover possibilities that impact Canada’s future and the world. At the NRC, you’ll also discover new possibilities. Our supportive workplace fosters a culture of creativity, welcoming fresh perspectives and innovation at all levels. We value teamwork. You’ll collaborate across multiple fields and with the brightest minds to find creative solutions. Most importantly, you’ll discover what’s possible within you as you grow, make valuable contributions and progress in your professional journey. From ground-breaking discoveries to a life-changing career, discover your possible at the NRC. The role The Director of Quality provides strategic and operational leadership for the Good Manufacturing Practice quality function supporting the development, manufacture, testing and release of Phase I biologics clinical trial materials produced in mammalian cell culture systems at the NRC Human Health Therapeutics Clinical Trial Material Facility. The role is accountable for establishing, maintaining and continuously improving a phase-appropriate GMP Quality Management System for early clinical biologics manufacturing. This includes quality oversight of mammalian cell culture, upstream and downstream processing, purification, formulation, fill-finish or transfer to fill-finish partners, analytical release testing, stability, materials management and product disposition. The Director of Quality ensures that investigational biologics are manufactured, tested, documented, stored and released in accordance with applicable GMP requirements, approved specifications, batch records, quality agreements, regulatory filings, client requirements and NRC policies. Screening criteria Applicants must demonstrate within the content of their application that they meet the following screening criteria in order to be given further consideration as candidates: Education Bachelor’s degree in life sciences, biotechnology, biochemistry, microbiology, chemistry, pharmaceutical sciences, biochemical engineering, chemical engineering, or a related discipline. Formal training in GMP, biologics manufacturing, quality systems, validation, regulatory affairs, aseptic processing, auditing, or quality. Advanced degree, such as MSc or PhD, is considered an asset. For information on certificates and diplomas issued abroad, please see Degree equivalency Experience Significant experience in GMP Quality Assurance or Quality Opera…