Manager, Batch Production Vaccines

Reference No. R2745824

Position Title: Manager, Batch Production – Vaccines

Duration: Fixed-Term - Contract End Date: March 27, 2026

Department: Document Management

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Key Responsibilities:

Create new Master Batch Production Records (mBPR) and revise existing ones as per area requests and change controls (CCRs), using the mBPR management system.

Ensure a consistent and efficient design by conforming to site and global quality directives, and regulatory and GMP requirements, while meeting needs of the shop floor staff. Provide guidance and make decisions and interpretations within broadly defined requirements.

Maintain the lifecycle of all mBPRs and Printing Packages in the mBPR management system and ensure timely turnaround of all documents.

Incorporate data integrity in design and facilitate FMEA risk analysis of mBPRs.

Liaise with various stakeholders across site including Quality Operations, Bulk Manufacturing, F&P, and Manufacturing Technology to facilitate the development and maintenance of mBPRs.

Led and support continuous improvement initiatives and regulatory commitment projects such as, new product/process development and Business Continuity Plan.

Provide support in troubleshooting and problem-solving system issues and connect with local support technical team or the vendor for support, as required and on a priority basis.

Assist in investigation of deviations related to system and department processes, using RCA methods. Provide input to ensure investigations are completed and effective CAPAs are designed and implemented prior to commitment dates.

Build and drive departmental CCRs in support of Change Control Leader.

Maintain departmental policy documents and ensure gaps to global directives and other related site policies are identified and addressed in a timely manner.

Act as SME on validation related activities related to changes/upgrade of the mBPR management system, and key user involvement in various activities, such as security matrix development, UAT design and execution, dry-run testing, and data migration and transition plan development, as required.

Manage priorities and meet critical timelines for both internal customers and regulatory agencies with moving priorities.

Interact and collaborate with regional counterparts on inter-site activities related to mBPRs, using excellent interpersonal and negotiation skills to ensure positive interaction.

Ensure inspection readiness of the area, mitigate risks, and provide inspection support.

Prepare and maintain training plans for various system roles and business support, and monitor system user access.

Track departmental and system performance through weekly and monthly metrics; identify and resolve issues accordingly, and escalate, as applicable.

Key Requirements:

Minimum Bachelor’s of Science or Engineering, or related field.

Minimum 5 (five) years pharmaceutical cGMP or similar related certification and experience

Strong background in all stages of biological product manufacturing is an asset

Excellent report writing and communication skills; demonstrated managerial skills and good judgement

Computer skills, previous experience with electronic systems and applications is an asset

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

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.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn:

#GD-SP #LI-SP

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!