Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden
Compliance Lead
Auf einen Blick:
Unsere Teams produzieren und liefern jedes Jahr über 4 Milliarden Einheiten an Medikamenten und Impfstoffen und sorgen dafür, dass jede Innovation die Menschen erreicht, die sie am dringendsten benötigen. Unsere hochmodernen Produktionsstätten, KI-gestützten Smart Factories und wegweisenden Automatisierungstechnologien setzen neue Maßstäbe – damit Behandlungen Patient*innen schneller, sicherer und nachhaltiger als je zuvor erreichen. Hier kannst Du mit Deinen Fähigkeiten, Deinen Ambitionen und Deiner Leidenschaft die Zukunft des Gesundheitswesens mitgestalten.
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.
Pursue Progress. Discovery Extraordinary.
Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.
Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.
Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und anderer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an Benefits-Programmen teilzunehmen.
Mehr Informationen über diesen Standort
Warum bei uns arbeiten?
- Wir stellen nicht nur Medikamente her – wir bewirken etwas. Unser globales Netzwerk modernster Produktionsstätten sorgt dafür, dass Patient*innen die Behandlungen erhalten, die sie brauchen – genau zur richtigen Zeit.
- Innovation treibt uns an. Von KI-gestützter Fertigung bis hin zu weltweit führenden Produktionsmethoden setzen wir neue Maßstäbe in Effizienz und Leistung.
- Hier wachsen Karrieren. Ob in der Produktion, Qualitätssicherung, Ingenieurtechnik oder in der Supply Chain– arbeitest Du mit erstklassigen Talenten zusammen, entwickelst Deine Fähigkeiten weiter und gestaltest die Zukunft der Pharmaindustrie mit.
- Wir tun, was richtig ist. Sicherheit, Nachhaltigkeit, Vielfalt, Gleichberechtigung und Inklusion stehen im Mittelpunkt unseres Handelns – für ein Arbeitsumfeld, in dem alle erfolgreich sein können.
All-In für Vielfalt
Bei Sanofi führen unterschiedliche Perspektiven zu den besten Lösungen für Patient*innen. Erfahre von Monique Vessey, unserer Leiterin der Supply Chain -Transformation, wie ihre persönliche Geschichte ihre Arbeit bei der Bereitstellung lebenswichtiger Medikamente prägt.
"Manufacturing & Supply bildet die Brücke zwischen der Wissenschaft in unseren Forschungslaboren und den Menschen und Gemeinschaften, die wir versorgen."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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