Compliance Lead

BioTalent Canada; Toronto; On-site; CAD 150,000 - 190,000; Full time

Job summary

Sanofi in Canada seeks a Compliance Lead within Country Quality Operations to oversee compliance programs, self-inspection, risk management, and establishment license management (DEL/MDEL) in alignment with Health Canada regulations.

The role requires 10–15 years in pharma, strong leadership, and experience with imported products. You will manage inspections, KPIs, and regulatory interactions to ensure ongoing compliance and readiness.

Qualifications

• University degree in science, recognized as equivalent in Canada.
• English: Excellent knowledge (reading, writing and oral).
• 10–15 years in pharmaceutical industry (QA, QC, Production or equivalent).
• 7+ years hands-on experience with imported pharmaceutical products and Health Canada regulations.
• Experience managing establishment licenses (DEL and MDEL).
• Strong management and leadership skills with cross-functional teams.

Responsibilities

• Develop and maintain an effective compliance program.
• Ensure site compliance with laws, regulations and standards for API (import) and Finished Goods (import/distribution).
• Maintain relationships with regulators and stakeholders; represent company in compliance matters.
• Drive risk management, self inspection, and quality alert management.
• Lead inspection readiness and inspection management activities.
• Define KPIs for site compliance and report results to management.
• Coordinate with global teams on GMP evidence and regulatory status for Canada.
• Oversee DEL and MDEL maintenance; manage vendor qualifications and quality agreements.

Skills

Regulatory compliance

GMP knowledge

Leadership

Risk management

Cross-functional teamwork

Education

University degree in science

Job description

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Our Team/ Overview:

The Compliance Lead is part of Country Quality Operations within MCCQ. The Compliance Lead oversees Country Quality compliance programs, self inspection, quality risk management and establishment license (DEL and MDEL) management in alignment with Canadian GMP regulations, as well as Corporate requirements.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Developing, implementing, and maintaining an effective compliance program.
• Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry for licensed activities related to API (importation only) and Finished Goods (importation and distribution)
• Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters.
• Maintaining a system to ensure compliance, regulatory and quality risks are properly identified, tracked, and mitigated.
• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance.
• Ensuring that any compliance issues or drug shortage issues, are reported to the relevant authorities in a timely manner and coordinating with multiple stakeholders to ensure timely responses to any related inquiries.
• Managing and resolving any compliance issues or allegations that arise, and taking appropriate corrective and preventive actions.
• Establishing and monitoring key performance indicators (KPIs) and metrics for site compliance and regulatory and reporting on the results to management.
• Responsible for driving risk management, self inspection, and quality alert management
• Identifying and driving continuous improvement initiatives and projects to enhance compliance and effectiveness, fostering a culture of compliance.
• Defining the potential regulatory and license impact of changes made to the site products and services.
• Ensuring compliance of imported products and medical devices with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates; decide and execute the regulatory compliance maintenance program for the site products.
• Develop and lead inspection management team to ensure operational effectiveness and compliance.
• Oversee the tracking, requesting, compilation and compliance status of GMP evidence from all foreign contractors to allow importation/distribution of products into Canada via valid Establishment License
• Responsible for maintaining the Canadian Drug Establishment License (DEL) and Medical Device Establishment License (MDEL)
• Manage Vendor qualifications including Audits and Quality Agreements with suppliers and/or clients, and ensure that commitments outlined therein are complied with
• Participate actively in new product launch and special project strategies, support marketing and business development groups
• Manage label changes and ensure labelling is compliant with Health Canada regulations.
• Medical Information Quality Support: Oversee Quality questions from Med Info department and participate in cross-functional teams to address complex patient and HCP inquiries
• Serve in a backup capacity to the Country Quality Head and the other Quality Leads for their respective responsibilities
• 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 our processes and systems

Assess acceptability of various strategies for imported products in view of complex Health Canada regulations for imported products

Proactively implement remediation action(s) from findings from internal and external GMP audit-/inspection-related topics and regulatory issues

Support senior management on compliance topics. Define and execute inspection readiness plan.

Coordinate quality alert and batch recall process with global team.

Decide for which changes a regulatory strategy must be established 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 the action plan to mitigate regulatory issues

Other duties as assigned

About You

Education and Language:

Must hold a university degree; this must be a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.

English: Excellent knowledge (reading, writing and oral)

French: Considered an asset

Experience:

10-15 years in 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

Strong management and leadership skills with demonstrated history

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whetherit’sthrough a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Takegood careof yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare,preventionand wellness programs.

AI Usage

“Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information toidentifypatterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s datasubject request portal, can also be used to request access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch ‘One day at Sanofi'(opens in new window) and check out our Diversity Equity and Inclusion initiatives at sanofi.com(opens in new window)

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.