Quality Assurance L2-1 in Toronto, Ontario

Position Name: Sterility Assurance Technical Manager, B100

Site/Department: Toronto/ Operational Quality & Sterility Assurance

Reporting To: Sterility Assurance Lead, B100

Location : Toronto, Ontario

Posting Date : Monday, August 14, 2024

Closing Date : Monday, August 20, 2024

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Quality Assurance within our Toronto/ Operational Quality & Sterility Assurance, is to be responsible for ensuring systems and processes to ensure sterility assurance and after the B100 project phase are developed, adhered to and sustained for routine commercial operations in alignment with established project strategies and plans. This position is responsible for providing expertise, quality oversight and guidance with regards to established requirements.

Vaccines

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

• Actively participates in project work stream meetings, planning and scheduling meetings and any related B100 requirements to ensure effective planning and execution of key sterility assurance deliverables.

• Review and approve critical project documentation including raw data packages, protocols and final reports across all sterility assurance programs.

• Creation and approval of APSS protocol(s) and report(s) along with oversight of APSS execution.

• Review, approve and maintain records of test requisitions for critical utilities and environmental monitoring sampling.

About you

• In-Depth Knowledge of Bio-Pharmaceutical Industry Compliance (i.e. cGxP, Current Industry Standards and Practices and Process/Environmental Engineering)

• Working Knowledge of Aseptic Manufacturing, Environmental Monitoring and Microbiology

• Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences or Engineering

• Related Industry Experience

• Working Knowledge of Fermentation, Cell and Viral Culture, Formulation and Stability

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 and at least 14 weeks’ gender-neutral parental leave.

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.

#GD-SP ​

#LI-SP

#LI-Onsite

​