Compliance Lead

Sanofi; Toronto; Hybrid; CAD 125,000 - 175,000; Full time

Job summary

Sanofi in Toronto seeks a Compliance Lead to oversee country quality compliance programs, self-inspection, risk management, and establishment license management for Canada.

You will drive inspection readiness, manage regulatory relationships, and lead continuous improvement initiatives to strengthen compliance across imported API and finished products.

Qualifications

• Must hold a university degree; Canadian-recognized in science related to work.
• Excellent knowledge of English (reading, writing and oral).
• French is considered an asset.
• 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.
• Experience managing establishment licenses (DEL and MDEL).

Responsibilities

• Developing, implementing, and maintaining an effective compliance program.
• Ensuring site compliance with laws, regulations, and standards for licensed API (importation only) and Finished Goods (importation and distribution).
• Establishing relationships with regulators, industry associations, customers, suppliers, and stakeholders; representing the company in compliance matters.
• Maintaining a system to identify, track, and mitigate regulatory and quality risks.
• Preparing for regulatory inspections and ensuring readiness for GMP inspections.
• Reporting compliance and drug shortage issues to authorities and coordinating timely responses.
• Managing and resolving compliance issues and implementing corrective actions.
• Defining KPIs and reporting site compliance to management.
• Driving risk management, self-inspection, and quality alert management.
• Identifying continuous improvement initiatives in compliance.
• Defining regulatory strategy for changes to site products and services.
• Leading inspection management to ensure operational effectiveness.
• Overseeing GMP evidence tracking from foreign contractors for Canada importation/distribution.
• Maintaining Canadian DEL and MDEL.
• Managing vendor qualifications including audits and quality agreements.
• Participating in new product launch strategies and cross-functional projects.
• Managing label changes to ensure Health Canada compliance.
• Overseeing QA support for Medical Information questions.
• Serving as backup to Country Quality Head and other leads.
• Managing QA staff and external consultants.
• Leading inspection readiness activities.

Skills

English fluency

Leadership

Regulatory knowledge

Education

University degree

Job description

Reference Number: R2853280 Position title: Compliance Lead Department: Quality & Operations Location: Toronto, ON

About the job

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: 10‑15years in pharmaceutical industry (QA, QC, Production or equivalent).
• Minimum7years 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, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and 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 data subject request portal,Data Subject Rights Webform.TheData Subject Rights Webformcan also be used torequest access or correction of your personal information and file a complaint.

Equal Opportunity

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

Accommodations for persons with disabilities required during the recruitment process are available upon request.

Salary and Benefits

The salary range for this position is: 124,800.00 - 174,800.00 (Includes target bonus) Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.

La fourchette salariale pour ce poste est la suivante: 124,800.00 - 174,800.00 (Comprend le bonus cible) La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.