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.

City:
Montréal

Organizational Unit:
Human Health Therapeutics

Classification: MGT-2

Tenure:
Term

Language Requirements:
Bilingual Imperative CBC/CBC

• 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.

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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.

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:

• 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…