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Manager, ETS Process Compliance - Vaccines

Synthorx

Synthorx

Legal
Toronto, ON, Canada
Posted on Tuesday, June 25, 2024

Position Title: Manager, ETS Process Compliance – Vaccines

Duration: Fixed-Term - Contract End Date: March 6, 2026

Department: ETS Compliance

Location: Toronto, Ontario

About the job

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 Manager, ETS Process Compliance within our ETS Compliance team, will be responsible for supporting CAPA planning, Deviation Investigations, ensuring ETS compliance and execution of continuous improvement initiatives within Engineering & Technical Services (ETS) department.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

  • Review CAPAs associated with recurring issues and escalate any issues to ETS Platform Leaders via Deviation/CAPA review board.

  • Coordinate the CAPA implementation timeline in coordination with ETS planning & scheduling team.

  • Ensure that investigation reports and/or manufacturing investigation reports and root cause analysis (RCA) are clear, concise, and comprehensive.

  • Support deviation investigation team to determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.

  • Lead and coordinate internal and external regulatory audits representing ETS

  • Lead cross-functional team meetings to review deviations/CAPA/CCR and topics relevant to ETS compliance

  • Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable

About you

  • Minimum B.Sc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science

  • 1-2 years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role.

  • High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment

  • Experience in regulatory inspections.

  • Experience with deviation management, CAPA, and change control.

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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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!