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Reference No. R2743022
Position Title: Supplier Quality Manager – Vaccines
Department: B100 Operational Readiness
Location : Toronto, Ontario
Sanofi Vaccines
Sanofi’s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Position Summary:
This role oversees quality processes with suppliers and service providers to ensure cGMP, regulatory, and internal compliance. It involves managing supplier change notifications, deviations, specifications, and change controls while fostering professional relationships and upholding Regulatory and Sanofi quality standards.
Key Responsibilities:
Management of Quality Agreements:
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Negotiate and Establish Quality and Technical Agreements with Third Parties, and other Sanofi entities for products, materials, and Services.
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Manage the lifecycle of Quality Technical Agreements (QTAs), including periodic reviews.
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Coordinate with Sanofi Global Third party and/or other entities to identify QTA requirements, establish and revise as required.
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Update and Maintain QTA records in Global Quality database.
Management of Third-party Materials and Services:
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Collaborate with Third Parties and internal teams for onboarding of new products, materials, and services.
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Coordinate with Third parties, Sanofi entities, and Global Third party department for required documentation to support onboarding and periodic review (e.g: QSMP, Validation, product technical information package etc.
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Maintain Global Quality database for quality third party materials and services used by site and ensure SAP ERP quality information records are in alignment with internal procedures. Ensure quality oversight on all managed materials and services, including specifications and assessments.
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Maintain quality information records in SAP and update QTA records in the Global Quality database.
Management of Third -Party Change Notifications :
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Liaison with Third parties, Sanofi Global Third Party to initiate, assess, TP change notifications.
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Collaborate with internal and Global teams to complete assessment of TP CN and associated CCR works on timely manner.
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Build and maintain networks within Sanofi and participate in global TPCN process.
Management of Third -Party Complaint Investigation:
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Liaison with Third parties, Sanofi Global Third Party to initiate, complete and escalate TP Complaint Investigation as required.
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Coordinate with Third Party and Operational Quality to Ensure completion complaint investigation in timely manner.
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Maintain KPIs related to Third-Party complaints and compliance management.
Third – Party Compliance Management:
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Lead and support CCRs and CAPAs to ensure timely completion.
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Manage the creation, review and approval of departmental procedures and ensure alignment to cGMP, regulatory and internal requirements.
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Monitor and communicate KPIs to senior management, suppliers, and service providers to ensure quality performance is consistently met.
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Perform TP annual performance assessment.
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Perform Annual review of QTAs.
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Perform annual review of TP complaints.
Context of the job/Major challenges:
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Strong understanding of applicable GxPs as relates to the assurance of quality for Third Parties and Service providers.
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Situational awareness and the ability to make decisions over the course of TP complaint investigations e.g., decisions about the adequacy of identified root cause(s) and corrective/preventive actions.
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Ability to work in cross-functional teams and collaboration with a diverse team of stakeholders (including external suppliers and service providers, as well as internal operational areas and teams) to ensure quality and compliance is maintained/established; strong collaboration, communication and negotiation skills are essential for this position.
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Fundamental understanding of biological manufacturing processes, validation (e.g., process, facility/equipment), analytical methods and procedures.
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Interact with various regulatory agencies during inspection, as well as auditors (Global Quality/Third Party).
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Strong verbal and written communication and technical writing skills to prepare accurate, clear and comprehensive documents.
Dimensions/Scope:
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Responsible to ensure that materials/services are of required quality and meet appropriate quality and regulatory standards.
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Works independently under minimal supervision and direction to complete planned activities e.g., determine adequacy of investigations performed by suppliers and service providers.
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Collaborate with internal and external stakeholders for the management of TP change notifications (approximately 150/year) and TP complaints (approximately 50/year).
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Participate in regulatory agency inspections/ Global Quality Audits as required.
Key Requirements:
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Bachelor of Science Degree in Chemistry, Biochemistry, or related field.
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Experience in GMP pharmaceutical/biological manufacturing, electronic database management (e.g., SAP), and Microsoft Office proficiency.
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Strong communication, interpersonal, and organizational skills.
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Competencies include technical writing, international GxP knowledge, and customer commitment.
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Strong technical writing and communication skills.
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Excellent knowledge of international G:xP requirements.
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Act for Change, Cooperate Transversally, Strive for Results, Commit to Customers.
Pursue Progress
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity, Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Follow Sanofi on Twitter: @SanofiCanada (https://twitter.com/SanofiCanada) and on LinkedIn: https://www.linkedin.com/company/sanofi
#GD-SP #LI-SP
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !