Compliance Lead

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 authorities promptly and coordinate responses with stakeholders.
• Manage and resolve compliance issues or allegations, taking corrective and preventive actions.
• Establish and monitor KPIs and metrics for site compliance, reporting results to management.
• Drive risk management, self‑inspection, and quality alert management.
• Identify and drive continuous improvement initiatives to enhance compliance and effectiveness, fostering a culture of compliance.
• Assess regulatory and license impact of changes to site products and services.
• Ensure compliance of imported products and medical devices with all relevant registrations, laws, regulations, standards, and guidelines in applicable markets; execute the regulatory compliance maintenance program.
• Lead the inspection management team to ensure operational effectiveness and compliance.
• Oversee tracking, requesting, compilation, and compliance status of GMP evidence from foreign contractors to allow importation/distribution via valid establishment license.
• Maintain the Canadian Drug Establishment License (DEL) and Medical Device Establishment License (MDEL).
• Manage vendor qualifications, including audits and quality agreements with suppliers and clients, ensuring commitment compliance.
• Participate in new product launch and special project strategies, supporting marketing and business development.
• Manage label changes, ensuring labeling complies with Health Canada regulations.
• Oversee quality questions from the Medical Information department and participate in cross‑functional teams to address complex patient and HCP inquiries.
• Serve as backup to the Country Quality Head and other Quality Leads.
• Manage QA staff and external consultants as required.
• Lead inspection readiness and inspection management activities.

Key Roles

• Define initiatives to improve the compliance and effectiveness of processes and systems.
• Assess the acceptability of various strategies for imported products under complex Health Canada regulations.
• Proactively implement remediation actions from internal and external GMP audit/inspection findings and regulatory issues.
• Support senior management on compliance topics.
• Define and execute inspection readiness plans.
• Coordinate quality alert and batch recall processes with the global team.
• Decide on regulatory strategies required for changes and provide the strategy.
• Develop remediation strategies for regulator and global Quality audit findings.Consult on product disposition decisions for quality and compliance issues.
• Define strategy for communicating and responding to regulators on quality and compliance issues.
• Inform senior management on action plans to mitigate regulatory issues.
• Other duties as assigned.

Qualifications

• Education: University degree in a science related to the work; Canadian or recognized by a Canadian university or accreditation body.
• Language: Excellent written and oral English; French considered an asset.
• Experience: 10–15 years in the pharmaceutical industry (QA, QC, production or equivalent), with at least 7 years hands‑on experience with imported pharmaceutical products and Health Canada regulations.
• Strong understanding of Canadian GMPs related to importation and distribution.
• Demonstrated experience managing establishment licenses (DEL and MDEL).
• Experience managing cross‑functional teams and external consultants.
• Proven track record in inspection management and regulatory authority interactions.
• Background in risk management and compliance program development.
• Strong management and leadership skills.

Salary

124,800.00 – 174,800.00 CAD (includes target bonus). Final compensation determined based on experience, skills, location, and other factors.

Equal Opportunity Employer

Sanofi is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.