Sanofi Group Batch Disposition Manager in Toronto, Ontario
Batch Disposition Manager
Department: Batch Disposition
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.
This person’s role is vital as independent quality review of critical manufacturing and test data to assure the consistent quality of each manufactured lot before it is marketed. The position is responsible for final batch disposition quality judgement release or reject in SAP) at media stage, drug substances and drug products stage,. Agency Batch lot release protocol preparation and submission.
Batch Disposition (80%) :
Perform final SAP batch disposition (release or reject) quality evaluation at media, seeds, drug substances (including adsorbed/dispensed stage of manufacturing) in accordance with SOP (Standard Operating Procedures).
Prepare and approve finished product co-package expiry memos, quarantine and distribution conditional use to allow for further manufacture.
Perform quality oversight for international shipment authorization).
Populate, review and approve and submit lot release protocols to regulatory agencies ensuring right first time accuracy throughout the process.
Prepare and submit responses to lot release queries from regulatory agencies in a timely manner.
An independent quality review of critical manufacturing and test data for each lot of vaccines is essential to assure the consistent quality of each manufactured lot before it is marketed. Escalation to Senior Management on quality events, resolution of conflicts and propose recommendations. Participation in Regulatory Inspections.
Quality Systems & Projects (20%):
Maintain training to perform the designated cGMP activities and meet Health Safety and Environment requirements.
Maintain Quality Systems (e.g. deviation, CAPAs, change controls, audits and inspections).
Collaborate with Sanofi sites and support projects that improve safety, quality, delivery, cost, involvement and strategic priorities.
Using excellent interpersonal and negotiation skills to ensure positive interaction with both internal and external customers.
Ability to meet critical timelines for both internal customers and regulatory agencies with moving priorities.
Education and Experiences:
Min Bachelors of Science
Min 5 years pharmaceutical cGMP experience (for US, Canada, Europe and International) with related Quality Batch Disposition (Release and Reject) or similar related certification and experience.
Strong background in all stages of biological product manufacturing.
Excellent report writing and communication skills; demonstrated managerial skills and good judgement.
Excellent interpersonal and negotiation skills are critical as the position requires extensive interaction with both internal and external customers (local and global).
Exceptional organizational skills. Ability to work within critical timelines.
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