Quality Compliance Manager

Purpose of the position

The Quality Compliance Manager is responsible for ensuring compliance with Health Canada requirements and global GMP standards. This role acts as the Marketing Authorization Holder (MAH) for Canada and supports internal Laval manufacturing operations for Canada, US markets, and several global customers. The position oversees compliance activities, manages regulatory licenses, and ensures readiness for audits and inspections. It also provides governance for escalated quality events and serves as the primary QA contact for Health Authorities.

 Main functions

• Serve as Marketing Authorization Holder for Canada, ensuring compliance with Health Canada regulations and company policies.
• Support Laval manufacturing operations for Canada, US markets, and global customers, ensuring adherence to GMP and regulatory requirements.
• Maintain product licenses and site licenses for Laval manufacturing and ensure timely renewals and updates.
• Act as QA liaison with Health Authorities during inspections, audits, and regulatory communications.
• Manage a portfolio of external suppliers and CMOs, ensuring compliance with quality agreements and Health Canada expectations.
• Lead management of escalated quality events, including critical deviations, recalls, and regulatory reporting.
• Provide timely updates and recommendations to Senior Management on significant compliance issues.
• Plan, execute, and oversee internal audits and external supplier audits to ensure compliance with Canadian and global GMP standards.
• Ensure readiness for Health Canada inspections and global regulatory audits.
• Oversee compliance with GMP documentation standards for Canadian operations and support continuous improvement initiatives.

Management responsibility

• Leads, organizes and supports the compliance team.
• Sets objectives for colleagues and ensures alignment with compliance goals.
• Ensures the development of employees, particularly through training plans focused on global GMP requirements.
• Identifies staffing needs and actively participates in recruitment processes.

Resources

• Manages the operational implementation of compliance projects according to the annual plan.
• Manages workforce priorities based on needs and deadlines.
• Defines action plans allowing optimization of compliance activities in terms of quality, costs, and timelines.
• Proposes organizational solutions to improve performance within scope of responsibility.

Main professional relationships (internal/external)

Reports directly to the Quality Assurance Director and acts as delegate if necessary.

Participates in multidisciplinary working groups.

Internal partners: Production, Purchasing, Planning, Quality Control, site CMC, Corporate functions.

External partners: Suppliers, External customers, and Health Authorities during audits and inspections.

Knowledge and skills required:

• Languages: French and English.
• Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Pharmacy).
• Minimum 5–7 years of experience in pharmaceutical quality systems, with at least 2 years in a leadership role.
• Strong knowledge of GMP regulations (FDA, EMA, ICH).
• Experience with electronic quality systems and document management platforms.
• Excellent communication, analytical, and problem-solving skills.
• Proven ability to lead cross-functional teams and manage multiple priorities.