Compliance Lead
Skills
About the role
This is a senior compliance role at Sanofi in Toronto, overseeing country quality compliance programs for imported pharmaceutical products. You'll manage self-inspections, quality risk management, and Canadian drug and medical device establishment licenses within a global biopharma company. It suits an experienced pharmaceutical quality or compliance professional with hands-on Health Canada regulatory experience.
What you’ll do
- Develop, implement and maintain an effective compliance program
- Ensure the site complies with pharmaceutical laws, regulations and standards for API and finished goods
- Maintain a system to identify, track and mitigate compliance, regulatory and quality risks
- Ensure inspection readiness for regulatory bodies related to dossier compliance
- Report compliance and drug shortage issues to relevant authorities
- Manage and resolve compliance issues, taking corrective and preventive action
- Establish and monitor KPIs for site compliance and regulatory reporting
- Drive risk management, self-inspection and quality alert management
- Maintain the Canadian Drug Establishment License (DEL) and Medical Device Establishment License (MDEL)
- Manage vendor qualifications, audits and quality agreements
- Oversee quality questions from the Medical Information department
- Manage QA staff and external consultants
What they’re looking for
- University degree recognized by a Canadian university or accreditation body in a science field
- 10-15 years in the pharmaceutical industry (QA, QC, Production or equivalent)
- Minimum 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
Nice to have
- French language proficiency
What’s on offer
- CAD 105,200.00 - 151,933.33 salary range
- Health and wellbeing benefits including healthcare, prevention and wellness programs
Questions about this role
Is this role remote?
The posting lists the role as Toronto, ON with no remote option mentioned; it is tagged internally as on-site (#LI-Onsite).
How much does it pay?
The salary range is CAD 105,200.00 to 151,933.33.
How many years of experience do I need?
10-15 years in the pharmaceutical industry, including at least 7 years hands-on with imported products and Health Canada regulations.
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