The Compliance Lead oversees Country Quality compliance programs, self-inspections, and establishment license management in alignment with Canadian GMP regulations
Job Summary
The Compliance Lead oversees Country Quality compliance programs, self-inspections, and establishment license management in alignment with Canadian GMP regulations.
This role requires ensuring the site complies with all laws and standards for licensed activities related to API importation and Finished Goods distribution.
Sanofi offers a thoughtful rewards package including high-quality healthcare, prevention programs, and opportunities for career growth at home or internationally.
Matching Summary
The Compliance Lead oversees Country Quality compliance programs, self-inspections, and establishment license management in alignment with Canadian GMP regulations.
Salary
Base: 124,800.00 - 174,800.00 CAD; Bonus: Includes target bonus; Benefits: Eligible for company employee benefits programs
Skills & Requirements
Must-have
Canadian GMP regulations expertise
Health Canada regulatory compliance
Establishment license DEL MDEL management
Importation and distribution compliance
Inspection readiness and management
Vendor qualification and audits
Risk management program development
Nice-to-have
French language skills considered asset
Experience with AI-powered biopharma
Cross-functional team leadership
New product launch support
Continuous improvement initiatives
Key Requirements
University degree in science from Canadian institution or equivalent
10-15 years experience in pharmaceutical industry
Minimum 7 years hands-on experience with imported pharmaceutical products
Strong understanding of Canadian GMPs for importation and distribution
Proven track record managing DEL and MDEL licenses
Demonstrated experience managing cross-functional teams and external consultants