Manager, BPR Review -Toronto/ON

Job description

Job Summary

As a member of the Product Quality team, provide support for the licensed products in managing day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices. The incumbent is expected to work independently as a Manager BPR Reviewer with a level of autonomy and authority for decision making to ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.

Major Duties and Responsibilites

Core Activities

·  Timely reviewing, follow-up, and approval of executed batch records, supplements, related checklists and PCMFs. Ensure through training, shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close contact with the various departments.
·  Ensure SAP/Phenix activities linked to executed BPR/supplement review are accurate and are completed in a timely manner.
·  Project team participation is also expected

Education

·  Specific degree, duration of experience (Required to hold the job):
·  Bachelor of Science degree specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.
·  Master of Science degree in Microbiology, Biochemistry or Immunology with 1+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.

Knowledge and Skills

·  Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically
·  Good understanding of GxPs
·  Regulatory and compliance trends
·  Excellent communication and interpersonal skills
·  Pays attention to details
·  Can make decisions when required.

Sanofi Pasteur: The world's leading vaccine company

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.

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

#GD-SP

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.