Job Information
Sanofi Group Manager, ETS Process Compliance – Vaccines in Toronto, Ontario
Position Title: Manager, ETS Process Compliance – Vaccines
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
3-5 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.
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.
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 (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 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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)