GMP Laboratory Director — Regulatory & Data Leader

Pathogenia Lab; Montreal (administrative region); On-site; CAD 180,000 - 240,000; Full time

Job summary

Pathogenia Lab seeks a Laboratory Director to oversee daily GMP operations, strategic direction, and regulatory compliance in a high-performing analytical lab in Montreal. You will lead a multidisciplinary team, manage resources, and ensure high-quality data generation for pharmaceutical products, from development through post-market surveillance.

You will drive FDA/HC alignment, oversee audits and CAPAs, and mentor staff while implementing continuous improvements and adopting new analytical

Qualifications

• Ph.D. or Master’s degree in relevant field with advanced knowledge.
• Strong leadership and team management experience in a regulated lab.
• Proven regulatory knowledge and ability to manage FDA/HC inspections.

Responsibilities

• Oversee laboratory operations, testing, method development, and documentation.
• Maintain compliance with FDA, HC, and other standards including audits.
• Lead quality assurance programs and drive continuous improvement.
• Coordinate projects, budgets, and resource allocation for efficiency.
• Interact with clients and regulatory agencies, presenting results clearly.
• Mentor staff and foster a collaborative, high-performing team environment.

Skills

Leadership

Communication

Problem solving

Budgeting & resource management

Team development

Education

Ph.D. in Chemistry or Pharmaceutical Sciences

Master’s in Chemistry or Pharmaceutical Sciences

Tools

LIMS

Job description

Pathogenia Lab seeks a Laboratory Director to oversee daily GMP operations, strategic direction, and regulatory compliance in a high-performing analytical lab in Montreal. You will lead a multidisciplinary team, manage resources, and ensure high-quality data generation for pharmaceutical products, from development through post-market surveillance.

You will drive FDA/HC alignment, oversee audits and CAPAs, and mentor staff while implementing continuous improvements and adopting new analytical