Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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’ performance.
- 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’ 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.
- 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.
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.
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