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Director of Quality - GMP Biologics Clinical Trial Material Facility

Priority 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.

OrganizationalUnit:Human Health Therapeutics

Classification:MGT-2

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 significant 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

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.
- Significant experience in GMP Quality Assurance or Quality Operations within a biologics, manufacturing environment, specifically with respect to production of material for Clinical Trials.
- Direct experience supporting GMP manufacture, testing and release of clinical trial materials.
- Experience with mammalian cell culture-based biologics manufacturing, including upstream cell culture, downstream purification and associated GMP controls.
- Demonstrated experience with core GMP quality systems, including batch record review, deviations, CAPA, change control, document control, supplier qualification, validation oversight and audit/inspection readiness.
- Experience applying phase-appropriate GMP expectations for investigational biologics, with sound risk-based and science-based quality decision-making.
- Experience leading, supervising, or mentoring quality professionals in a clinical trial material facility.
- Experience in managing operation activities as a production manager or supervisor is an asset.

Condition of employment

A thorough security clearance process will be applied.

For a Secret Clearance, verification of background information over a period of 10 years is required. Individuals must have lived in Canada for a sufficient period of time to enable the security screening process.

Language requirements

Note: In the event that no qualified bilingual candidates are identified, NRC may consider unilingual candidates who will be required to commit to achieving these levels within two years.

Candidates will be assessed on the basis of the following criteria:

- Expert knowledge and understanding of current and emerging GMP, regulatory, scientific, technical and business issues, including the organizational and external factors that influence the successful manufacture, testing, release and supply of Phase I biologics clinical trial material;
- Knowledge of mammalian cell culture-based biologics development and manufacturing practices, including upstream cell culture, downstream purification, formulation, analytical testing, stability, contamination control and the effective use of GMP manufacturing infrastructure, single-use technologies,



cleanrooms and specialized quality systems;
- Solid ability to lead and manage multidisciplinary GMP quality teams, effectively leveraging organizational capabilities while balancing patient safety, regulatory compliance, scientific excellence, operational delivery and program relevance for production of material for Clinical Trials;
- Advanced knowledge in GMP quality systems and quality risk management, including deviation and CAPA management, change control, batch record review, supplier qualification, validation and qualification oversight, data integrity, inspection readiness and phase appropriate release of investigational biologics;
- Ability to lead and inspire organizational change, applying best practices in quality management, human resources, financial oversight, operational efficiency and continuous improvement to strengthen GMP compliance and facility performance;
- Excellent communication skills to work collaboratively with a wide range of internal and external stakeholders, including clients, clinical sponsors, manufacturing and analytical teams, regulatory authorities, auditors, partners and NRC leadership.
- Management Competencies - Inspirational leadership (Level 3)
- Management Competencies - Drive for results and efficiency (Level 4)
- Management Competencies – Client Relationship Management (Level 4)
- Management Competencies – Industry Sector Knowledge (Level 4)

NRC employees enjoy a wide-range of competitive benefits including a robust pension plan, comprehensive health and dental coverage, disability and life insurance, office closure at the end of December, and additional supports to enhance your well‑being throughout your career and beyond.

Notes

- In 2026, the NRC was chosen as one of Canada’s Top Employers for Young People, a National Capital Region Top Employer and Forbes Canada’s Best Employer.
- Relocation assistance will be determined in accordance with the NRC's directives.
- A pre-qualified list may be established for similar positions for a one-year period.
- Preference will be given to Canadian Citizens and Permanent Residents of Canada. Please include citizenship information in your application.
- The incumbent must adhere to safe workplace practices at all times.
- We thank all those who apply, however only those selected for further consideration will be contacted.

Please direct your questions, with therequisition number (26240) to:

Closing Date: 6 November 2026 - 23:59 Eastern Time

*If you are currently a term or continuing employee at NRC, please apply through the SuccessFactors Careersmodule from your NRC computer.

📌 Director of Quality - GMP Biologics Clinical Trial Material Facility (Montreal)
🏢 National Research Council of Canada
📍 Montreal