Good Manufacturing Practices

2 weeks ago


Montréal, Canada National Research Council Canada Full time

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.

**City**: Montreal

**Organizational Unit**: Human Health Therapeutics

**Classification**: RCO

**Tenure**: Term

**Duration**:Two (2) years

**Language Requirements**: Bilingual Imperative CBC/CBC
**Work arrangements**:Due to the nature of the work and operational requirements, this position is eligible for a hybrid work arrangement (combination of working onsite and telework). Employees in this position who telework will be required to travel to the identified work site at least four (4) times per week at their own expense.

**The role**:
We are looking for a Good Manufacturing Practices (GMP) Information Systems Manager to support our Human Health Therapeutics (HHT) Research Centre. The incumbent would be someone who shares our core values of Integrity, Excellence, Respect and Creativity.

The GMP Information Systems Manager is responsible for the strategic planning, procurement, oversight, and compliance of all IT systems supporting GMP-regulated operations. This role ensures systems are validated, aligned with regulatory requirements, Government of Canada (GoC) best practices and support the organization’s manufacturing, quality, and regulatory objectives. The Manager acts as a key liaison between IT, Quality, and Operational stakeholders, leading digital transformation efforts while safeguarding system integrity. The Manager will own the Clinical Trial Material Facility (CTMF) IT governance, validation, and compliance strategies, and will act as the principal IT representative during inspections by health authorities such as Health Canada, Food and Drug Administration (FDA) and European Medicines Agency (EMA).

**Screening criteria**:
**Education**:
Bachelor’s degree in Information Systems, Engineering, Computer Science or a related field.

For information on certificates and diplomas issued abroad, please see Degree equivalency

**Experience**:

- Extensive* experience planning, overseeing and ensuring compliance of IT systems in a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Experience supporting regulatory inspections and managing audit-related IT activities.
- Extensive* experience on the selection process for implementation of IT infrastructure and WIFI solutions.
- Extensive experience is defined as ten (10) years of experience.

**Condition of employment**:
Reliability Status

For a Reliability Status, verification of background information over a period of 5 years is required.

**Language requirements**:
Bilingual Imperative CBC/CBC

Information on language requirements and self-assessment tests

**Assessment criteria**:
**Technical competencies**:

- Advanced knowledge of GMP regulations, data integrity, and computer system validation (CSV).
- Knowledge of IT Production Information Management System (PIMS) and Enterprise Resource Planning (ERP) System platforms.
- Knowledge of IT service management frameworks such as Information Technology Infrastructure Library (ITIL)
- Ability to translate technical language to business context.

**Behavioural competencies**:

- Management services - Communication (Level 3)
- Management services - Networking (Level 2)
- Management services - Results orientation (Level 3)
- Management services - Teamwork (Level 3)

**Competency Profile(s)**:
**Compensation**:
The intent of this hiring action is to staff this position at the **RCO-4** level with a salary range of **$143,127** to **$168,192**.

In addition, the incumbent who meets the language requirements will receive the Bilingualism Bonus of $800 per year.

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.

**Discover the possible**:
Anything is possible at the National Research Council (NRC), recently named one of Canada’s 2025 Top Employers for Young People, a 2025 Top Employer in the National Capital Region and Forbes Canada’s Best Employers

As Canada’s leading research and technology 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



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