Change Management à Canada

Direct message the job poster from Centre de recherche du CHUM (CRCHUM)

Dr. Simon Turcotte, Medical Director of the Cellular Production Unit (UPC), and his team are looking to hire a Quality Assurance Coordinator. The UPC is developing new cellular products based on anti-tumor T lymphocytes to enable the launch of Phase I/II clinical trials in the near future.

Under the supervision of Dr. Turcotte and in collaboration with the UPC's cell production managers and the clinical research quality team, you will actively contribute to strengthening the quality framework of the UPC. The unit includes state-of-the-art clean rooms and specialized equipment for manufacturing cellular therapies.

Quality Management System

• Develop, implement, and maintain the quality management system in accordance with regulatory requirements (Health Canada and FACT).
• Write, review, and update Standard Operating Procedures (SOPs) and other quality policies.

Regulatory and Normative Compliance

• Ensure compliance with GMP, GLP, and GCP.
• Coordinate and prepare for inspections and external audits by regulatory authorities and sponsors.
• Develop and implement an internal audit plan.

Validation and Qualification

• Oversee equipment, facilities, and utilities qualification (IQ/OQ/PQ).
• Validate manufacturing, cleaning processes, and analytical methods.

Change Management and Continuous Improvement

• Analyze change requests and assess their impact on quality and compliance.
• Implement continuous improvement initiatives to optimize quality processes.
• Stay current on regulatory and technological developments.

Training and Awareness

• Develop and deliver training on quality and regulatory requirements.
• Promote best practices and a strong quality culture among the team.

• Bachelor's degree in life sciences or a related field
• Minimum of 3 years of relevant experience, including substantial experience with Good Manufacturing Practices (GMP)
• Knowledge of Canadian and international GMP regulations
• Proven experience in developing a quality plan (even partially)
• Knowledge of FACT standards is an asset
• Knowledge of clinical research standards is an asset
• Strong communication skills in both French and English
• Ability to adapt and manage multiple tasks simultaneously
• High degree of autonomy
• Strong interpersonal skills, attention to detail, and a results-oriented mindset

• Full-time position, 35 hours per week, daytime schedule (Monday to Friday)
• Flexible hours and remote work possible
• Start date: As soon as possible
• Salary range: $30 to $53 per hour depending on experience
• Employee benefits according to CRCHUM policies
• 20 vacation days per year after one year
• 13 paid holidays
• 9.6 paid sick days
• Non-unionized position
• Pension plan (RREGOP) starting from day one
• Group insurance

Interested candidates should send their resume to:

mathieu.gigoux.chum@ssss.gouv.qc.ca

We thank all applicants for their interest, but only those selected for a test or interview will be contacted.

CRCHUM encourages applications from women, Indigenous people, visible minorities, ethnic minorities, and individuals with disabilities.

CRCHUM embraces a broad and inclusive definition of diversity, going beyond applicable laws. We encourage all individuals, regardless of their background, to apply.

Please note: In accordance with Canadian immigration requirements, priority will be given to Canadian citizens and permanent residents.

• Mid-Senior level

• Full-time

• Quality Assurance
• Industries
• Hospitals and Health Care