Manager, Quality Compliance

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

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

Resources

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 :

We are an Equal Opportunity Employer. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.

Required Experience :

Manager

Key Skills

Abinitio,Apprentice,Dermatology,Cost Estimation,Data Networking,Liaison

Employment Type : Full Time

Experience : years

Vacancy : 1