Sanofi Group Manager, Vaccine Product Compliance in Toronto, Ontario
Manager, Vaccine Product Compliance
Reference #: R2490729
Department: Quality Operations
Location: Toronto, Ontario
About Sanofi Pasteur
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 Manager, Vaccine Product Compliance is responsible for creation and submission of Health Authority notifications such as Biological Product Deviation Report (BPDR). The Manager, Vaccine Product Compliance i s responsible for creation and negotiation of Quality Technical Agreements (QTAs) with suppliers and service providers. The incumbent will also be responsible for supporting the Product Surveillance team in investigating complaints and creating Annual Product Quality Reviews (APQR).
Complete lifecycle management of the Biological Product Deviation Reports (BPDR) including coordination, preparation, review, submission and tracking of documents amendments.
Lead creation and negotiation of Quality Technical Agreements (QTAs) for material suppliers and service providers
Prepare trend reports and update department SOP
Provide support during external inspections, global audits and/or third party audits
Supports department initiatives and groups within product surveillance team (APQR and Complaint investigations)
Ensure product(s) is current with a changing regulatory environment, new approaches to manage quality systems, and the changing environment of industry standards.
Ensure compliance of prepared documentation with the appropriate government regulations; maintain up-to-date knowledge of GMP
Ability to contribute as a subject matter expert (SME) within a matrix team and communicate clearly GMP requirements
Education & Experience:
Min Bachelors Degree in Sciences or related field
Min 5 years of experience in a GMP controlled/pharmaceutical industry
Min 2 years experience with Biological Product Deviation Reports (BPDR), Quality Technical Agreements (QTAs) and Annual Product Quality Reviews (APQR)
Thorough knowledge of GMPs and regulatory requirements (Health Canada and FDA) are required
Excellent organizational, interpersonal and teamwork abilities are required
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.
Sanofi, Empowering Life
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 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.
Sanofi, Empowering Life