Sanofi Group Technical Manager, Quality Operations Sterility Assurance Clean Utilities in Toronto, Ontario

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.

Job Overview

The Technical Manager within the Quality Operations Sterility Assurance Clean Utilities team is responsible for providing technical and administrative support to the Clean Utilities Monitoring Program and to Disinfectant validation program. It is to ensure that Clean Utilities Systems Program and Disinfectant efficacy Program are aligned with regulatory requirements and defined within robust policies and procedures to provide assurance of quality to meet the continuous availability of Clean Utilities and disinfectants for production. This position requires on-going collaboration with various technical and quality professionals from Quality and other key Departments (e.g. QO, Facility Management, Production, and Manufacturing Technology) at the site.

Key Responsibilities

  • Support the maintenance of the Site Clean Utilities program to ensure that routine sampling and testing of utilities is aligned with regulatory, global and site requirements.

  • Provide technical support, direction to non-conformance investigations and review and approve non-conformance events.

  • Conduct periodic shop floor surveillance and perform data analysis for on-going utility monitoring.

  • Develop, review and/or approve SOPs and technical documents.

  • Develop training modules and conduct training as required.

  • Develop technical strategies to support various improvement activities within Clean Utilities and Disinfectant validation.

  • Support preparation/Review and approval of Utilities Trend reviews and reports.

  • Provide Utilities assessments for Annual Product Reviews.

  • Review Utilities Operational SOPs to ensure that maintenance and operation of Clean Utilities is performed in alignment with regulatory, global and site requirements.

  • Support any sterility assurance related inspection readiness activities.

  • Stay current with changing regulatory environment, new technologies, and qualification approaches in the field of sterility assurance.

  • Participate in Industrial Committees (e.g. PDA, ISPE, ISO).

  • Work within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Required Qualifications

  • Bachelor of Science in Biology, Microbiology, Applied Pharmaceutical Sciences, Engineering

  • Three (3) to five (5) years of related industry experience in sterile manufacturing

  • Experience in working in the laboratory setting, validation, quality design

  • Mechanical aptitude and preferably experience in reviewing facility and utility related drawings

  • Proficient in experimental design, computing and the use of statistical tools

  • Detail oriented, proficient in performing or familiar with risk assessment, gap and statistic control analysis

  • High degree of autonomy and ability to make decisions

  • Excellent interpersonal, communicative (both verbal and writing) and presentation skills

  • Relevant immunization and medical clearance are required

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.

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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