GMP Quality Director - Biologics Clinical Trials

National Research Council Canada / Conseil national de recherches Canada; Montreal; On-site; CAD 153,000 - 184,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

National Research Council Canada (NRC) in Montréal seeks a Director of Quality to lead the GMP quality function for Phase I biologics clinical materials produced in mammalian cell culture.

The role establishes and maintains a phase-appropriate GMP Quality Management System, overseeing upstream/downstream processes, analytical release, and deviations, CAPA, and regulatory filings while ensuring compliance and product disposition.

Qualifications

• Bachelor’s degree in life sciences or related discipline with GMP training.
• Advanced degree (MSc/PhD) is an asset.
• Significant experience in GMP Quality Assurance or Quality Operations in a biologics manufacturing environment.
• Experience supporting GMP manufacture, testing and release of clinical trial materials.
• Knowledge of mammalian cell culture-based biologics production and GMP controls.

Responsibilities

• Provide strategic and operational leadership for GMP quality functions in Phase I biologics production.
• Oversee quality management system for early clinical manufacturing, including release testing and stability.
• Ensure products are manufactured, tested, stored and released per GMP requirements and regulatory filings.
• Lead, mentor and manage quality professionals in a clinical trial material facility.
• Collaborate with internal and external stakeholders to ensure quality and compliance.

Skills

GMP knowledge

Quality assurance

Regulatory understanding

Communication skills

Education

Bachelor's degree in life sciences or related

Advanced degree (MSc/PhD) asset

Tools

GMP systems

CAPA

Change control

Job description

National Research Council Canada (NRC) in Montréal seeks a Director of Quality to lead the GMP quality function for Phase I biologics clinical materials produced in mammalian cell culture.

The role establishes and maintains a phase-appropriate GMP Quality Management System, overseeing upstream/downstream processes, analytical release, and deviations, CAPA, and regulatory filings while ensuring compliance and product disposition.