Sanofi Group Professional Health, Safety and Environment Biosafety in Toronto, Ontario

The Manager, Biosafety is responsible for ensuring strategic oversight and implementation of the biosafety and biosecurity (Biorisk) programs at Sanofi Pasteur’s Toronto facility. This includes leadership and direction on the biosafety program and ongoing compliance for operations. This position works closely with and provides leadersip to department Directors and Managers, the site Biosafety Committee and HSE Risk Committee. The Manager will report to the Senior Director, Health, Safety and Environment (HSE), provide leadership to management on biosafety and in assuring compliance and maintenance of the HPTR license to operate.

Key Accountability

  • Work collaboratively with Directors and senior managers, provide leadership and guidance to manufacturing, quality, research and development operations and continually improve the site’s biosafety program, including assurance of compliance with the applicable requirements of the Canadian Biosafety Standards and the conditions of the Human Pathogens and Toxins Licences as issued by the Public Health Agency of Canada.

  • Lead the development, implemention and maintenance of a comprehensive, site-wide biosafety program and manual to promote biocontainment and safe practices with activities involving human pathogens and toxins and ensure compliance with applicable federal and provincial regulations.

  • Act as Biosafety Officer, provide leadership to senior management, communicate with the Public Health Agency of Canada on the site’s behalf, perform duties outlined in the Human Pathogens and Toxins Act and Regulations, including, but not limited to, promoting and monitoring compliance with licenses.

  • Conduct legislated biosafety inspections/audits to verify procedures and standards are rigorously followed, report findings to Directors and inform License Holder of any non-compliance.

  • Oversee the development and delivery of training related to applicable biosafety and biosecurity compliance, risks, policies, standards and practices.

  • Provide technical support, advice and guidance on biosafety and biosecurity matters related to facility containment/ design, operational procedures, practices and biocontainment equipment.

  • Lead and facilitate biosafety risk assessments to identify risks and support the implementation of applicable controls.

  • HSE Team Support. Act as an HSE contact for client/departmental support as needed, participate in on call rotation to ensure 24/7 coverage of site operations.

  • Other HSE duties as assigned.

Education and experience

  • Minimum: Certified Biological Safety Professional (CBSP) or Advanced degree (M.S., MPH) in a related field of natural science (biology, microbiology, health sciences) or other related field from an accredited college or university .

  • A minimum of 5-10 years of practical HSE experience, with a minimum of seven (7) years biosafety experience managing a biosafety program.

Key technical competencies and soft skills:

  • Excellent knowledge of biosafety, biosecurity, biocontainment standards, principles and practices. Strong knowledge of related regulatory requirements, specifically the Canadian Biosafety Standards and the Human Pathogens and Toxins Act and Reggulations. Strong knowledge and understanding of biological risk assessment, large-scale biosafety issues, biomedical waste management practices (disinfection, decontamination and sterilization )and personal protective equipment necessary for biocontainment facilities. Working knowledge of facility/containment design and the ability to understand and interpret facility drawings as they relate to bicontainment

  • Influencing, coaching and mentoring of individuals at director and manager level, excellent communication skills (written, verbal and presentations). Systems thinking, change management, investigational, inspection and auditing skills.The abiliy to work transverally across functions/departments, and strong team work within the HSE team. Providing educational, monitoring, support service functions while being flexible by using creative and innovative approaches to problem solving.

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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

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