Lead pharmaceutical quality assurance and regulatory compliance work as a Senior Consultant based in Canada, supporting GMP documentation and product release.
This senior position supports pharmaceutical, medical device, natural health product, and clinical trial supply operations. You will coordinate licences, manufacturing sites, client documentation, and Canadian product releases. The work includes quality systems, regulatory requirements, and operational processes across clients and international sites.
Key Responsibilities:
- Maintain importer DELs, MDELs, SLs, and applicable establishment licences
- Coordinate international manufacturing and supplier site approvals
- Review GMP documentation and product release records
- Investigate deviations, complaints, and change controls
- Support audits,
inspections, recalls, and quality reporting
Requirements:
- Bachelor's degree in pharmaceutical or healthcare-related discipline
- At least 5 years of qualified Quality Assurance experience
- Knowledge of Food and Drugs Act and Health Canada GMP regulations
- Understanding of GCP, GMP, GDP, and data integrity principles
- Experience with root cause analysis and CAPA implementation
Apply regulatory expertise, quality systems knowledge, and product release experience across Canadian healthcare and pharmaceutical operations.