Fabrication et Approvisionnement
Là où les miracles
de la science
deviennent une réalité pour les patients
Compliance Lead
En bref
Nos équipes produisent et livrent chaque année plus de 4 milliards de médicaments et de vaccins, veillant à ce que chaque avancée soit accessible à ceux qui en ont le plus besoin. Grâce à des infrastructures ultra-modernes, des usines intelligentes pilotées par l’IA et une automatisation de pointe, nous repoussons les limites pour garantir que nos traitements parviennent aux patients plus rapidement, en toute sécurité et de manière plus durable que jamais. C’est ici que votre expertise, votre ambition et votre passion peuvent façonner l’avenir de la santé.
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’rean 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, 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, toanalyzedata and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, 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 aboveand calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your 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.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop andretainhighly talentedemployees from diverse backgrounds, allowing us tobenefitfrom a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilitiesrequiredduring 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.
Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.
Toujours Progresser. Découvrir l’Extraordinaire.
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, et autres facteurs objectifs. Les employés seront également éligibles aux programmes d'avantages sociaux de l'entreprise.
En savoir plus
sur ce site
Pourquoi nous rejoindre ?
- Nous ne faisons pas que fabriquer des médicaments—nous créons un impact. Grâce à notre réseau international d’installations de pointe, nous veillons à ce que les patients reçoivent les traitements dont ils ont besoin, au moment où ils en ont besoin.
- L’innovation est notre moteur. De la fabrication pilotée par l’IA aux méthodes de production inédites, nous repoussons les limites de l’efficacité et de la performance.
- Ici, vous évoluez. Que ce soit en production, en qualité, en ingénierie ou en supply chain, vous collaborerez avec des experts de renom, développerez vos compétences et contribuerez à façonner l’avenir de l’industrie pharmaceutique.
- Nous faisons ce qui est juste. Sécurité, durabilité, diversité, équité et inclusion sont au cœur de notre engagement, garantissant un environnement où chacun peut s’épanouir.
Tous engagés pour la diversité
Chez Sanofi, la diversité des perspectives est une source d’innovation au service des patients. Découvrez Hamza Laajaj, Chef de projet déploiement applicatif à Neuville-sur-Saône, et son engagement pour un environnement inclusif où chaque voix compte. Pour lui, c’est en embrassant la diversité que nous libérons l’innovation et repoussons les limites de la santé.
"Nous faisons ce qui est juste. Sécurité, développement durable, diversité, équité et inclusion sont au cœur de notre engagement, garantissant un environnement où chacun peut s’épanouir."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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