Compliance Lead

Responsibilities

• Develop, implement, and maintain an effective country quality compliance program.
• Ensure site compliance with all laws and regulations for API importation and Finished Goods distribution.
• Manage and maintain Canadian Drug Establishment Licenses (DEL) and Medical Device Establishment Licenses (MDEL).
• Establish and maintain relationships with regulators, industry associations, and other key stakeholders.
• Identify, track, and mitigate regulatory and quality risks through robust risk management systems.
• Lead inspection readiness activities and manage the response to regulatory body inspections.
• Oversee vendor qualifications, including audits and quality agreements with suppliers and clients.
• Drive continuous improvement initiatives to enhance compliance culture and operational effectiveness.
• Manage QA staff and external consultants as required to support quality objectives.

Requirements

• University degree in a science-related field (Canadian degree or equivalent).
• 10-15 years of experience in the pharmaceutical industry (QA, QC, or Production).
• Minimum of 7 years of hands-on experience with Health Canada regulations and imported pharmaceutical products.
• Strong knowledge of Canadian GMPs related to importation and distribution.
• Demonstrated experience managing DEL and MDEL licenses.
• Proven track record in inspection management and interacting with regulatory authorities.
• Strong leadership and management skills with experience leading cross-functional teams.
• Excellent English communication skills (written and oral); French is considered an asset.

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We use our deep understanding of the immune system and an innovative pipeline to invent medicines and vaccines that treat and protect millions of people around the world.