Job Description

Reference No. R2713241

Position Title: Technical Lead, QC Analytical Excellence - References & Critical Reagents

Department: References & Critical Reagents

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\xe2\x80\x99s 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:

The Technical Lead at QC Analytical Excellence -- References and Critical Reagents (R&CR) is responsible for providing technical guidance for all activities related to the qualification and use of Reference Standards and Critical Reagents for QC tests. The individual is responsible for monitoring the performance of R&CR through quarterly auditing, managing expiry date extensions, planning and scheduling qualification activities, procuring reagents and managing timely implementation. The incumbent will drive and manage the change controls related to References and Critical Reagents qualifications to ensure changes are managed properly and timely through the change control process. This role includes troubleshooting activities related to reagent qualification and supporting investigations pertaining to reagents\xe2\x80\x99 performance.

Key Responsibilities:

• Manage activities related to qualification of References and Critical Reagents in all QC labs. Proactively manage qualification schedule based on depleting inventory, upcoming expiry dates and reagent performance. Work with cross-functional teams to ensure timely procurement, qualification and implementation.
• Drive and manage the change controls related to qualifications of references and critical reagents. Manage expiry date extensions of critical reagents by assessing reagent performance and collaborating with QC labs and QOVS.
• Audit trend data for all QC labs, collaborate with QC Managers to initiate investigations as it pertains to reagents\xe2\x80\x99 performance, determine appropriate corrective actions and drive implementation.
• Manage activities internally between QC labs, Sample Management, HSE, Toronto Export group and Shipping department to ensure reagents are shipped in accordance with internal and external policies/regulations. Assess impact for temperature excursions and determine go/no-go decision.
• Support training/budget/schedule activities to maintain high performing team, aligning team activities with functional groups on site to successfully fulfill all commitments. Delegate tasks as appropriate and develop indirect reports.
• Support global initiatives and site projects as required.

Dimensions and Scope:

• Position liaises across QC, OQ, QOVS, RA, Convergence, Supply Chain, and other Sanofi Pasteur sites.
• The incumbent will make decisions on qualification and supply of Reference Standards and Critical Reagents
• Responsible for interpretation of cGMPs and industry guidance to achieve required compliance levels.

Key Requirements:

• Minimum B.Sc. degree in Immunology, Microbiology, Biochemistry or a related discipline and five (5) or more years of relevant experience.
• Strong GMP background including working knowledge of GLP/GMP
• Strong supervisory, and both written and oral communications skills
• Strong analytical, organizational and balanced decision-making skills.
• Ability to multi-task and work in a fast-paced environment with constant switching of priorities and tight timelines.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.

Watch our and check out our Diversity, Equity and Inclusion actions at !

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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Sanofi