Sanofi Group B100 Operational Preparedness Manager, Computerized Systems - Vaccine in Toronto, Ontario
Reference No. R2578655
Position Title: B100 Operational Preparedness Manager, Computerized Systems - Vaccine
Department: IMS B100
Location: Sanofi Pasteur Limited, Toronto, Ontario
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.
Building 100, a new Vaccine manufacturing facility being constructed at our Toronto site, is an extremely exciting and complex project that will position Sanofi Pasteur on the cutting edge of the digital evolution of biopharmaceutical manufacturing. The IMS team is at the forefront of the transformation and this position will challenge individuals to work as part of dynamic, cross functional and multi-disciplinary team both locally and globally.
Possessing a unique combination of skills in the areas of vaccine manufacturing, computerized systems, quality/compliance and technical writing, the Operational Preparedness Manager is responsible for ensuring procedures are in place to govern the use of B100 computerized systems used in manufacturing activities (including MES, PI, PCS and others). The Operational Preparedness Manager will ensure these procedures are fully aligned with business objectives and quality/compliance regulations while taking full advantage of electronic system capabilities. This position requires the ability to work collaboratively with multiple project and site stakeholders/departments including ITS, Engineering, Operations and Quality.
Conduct analyses to identify required procedures/controlled documents related to the administration and operation of B100 computerized systems (such as MES, PI, PCS and others) to ensure B100 production operational readiness:
- These may include, but are not limited to SOPs, SWIs, protocols, specifications, reports and others related to batch record design and content requirements, periodic review of data, batch record review/release, change control, etc.
In collaboration of project/site departments, author, maintain, review and approve above documents, as required:
- Train end users on changes made to existing site procedures as well as implementation of new procedures affecting B100, where required.
Contribute to the creation and implementation of the B100 data integrity strategy by developing risk assessment templates, performing risk assessments and conducting data mapping exercises:
- This includes contributing to data integrity assessments of manufacturing equipment and supporting MES/eBR design and revision
Review/assess change controls, deviations and corrective actions within IMS perimeter.
Identify opportunities for B100 alignment with site or across Bulk Manufacturing platforms:
- Provide IMS support for site-wide initiatives/continuous improvement projects related to Quality systems, processes and procedures.
Fulfill role of role of system administrator for various production equipment (such as benchtop instruments), as required.
Ensure tasks are delivered to support B100 timelines.
Education & Experience:
University/College degree biological science, engineering or equivalent field
Minimum 5 years of experience in pharmaceutical/biotech manufacturing, particularly the areas of Operations and Quality/Compliance
Strong background in all stages of biological product manufacturing
Excellent verbal/written communication and technical writing skills
Experience with Computerized Systems including ERP, MES, SCADA would be an asset
Efficient in the use of Quality systems such as Change Controls and CAPAs, and company tools (e.g. SAP, Phenix, PharmNet Web etc.)
Demonstrated ability to work independently within a matrix project team
Demonstrated understanding of current Good Manufacturing Practices
Demonstrated aptitude in problem solving and continuous improvement
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.