Job Description
Job Summary
Compliance Lead – Quality & Operations – Toronto, Ontario. The role oversees country quality compliance programs, self‑inspection, risk management, and establishment license (DEL and MDEL) management in alignment with Canadian GMP regulations and corporate requirements.
Responsibilities
- Develop, implement, and maintain an effective compliance program.
- Ensure site compliance with all applicable laws, regulations, and standards for API (importation only) and finished goods (importation and distribution).
- Establish and maintain relationships with regulators, industry associations, customers, suppliers, and other stakeholders, representing the company in compliance matters.
- Maintain a system to identify, track, and mitigate compliance, regulatory, and quality risks.
- Prepare the company for inspections by regulatory bodies on dossier compliance.
- Report compliance issues or drug shortage issues to au...