Manager Quality Control Microbiology – EM Testing

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City : Toronto

Category : Production

Industry : Pharmaceutical

Employer : Sanofi

Manager, Quality Control (QC) Microbiology -EM Testing

Reference #: 2499533

Department: Microbiology

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.

Position Summary

The QC Microbiology Manager is responsible for the supervision of various testing activities within QC Microbiology department, in compliance with cGMP and Quality systems. Responsible for planning and scheduling to ensure efficient and effective microbiology testing of raw materials, in process & finished products, the site’s environmental and utility system monitoring programs, aseptic broth simulation studies and validation of sterilization processes. Responsible for the test approval following GMP and site SOPs. Maintain quality and compliance procedures of the QC Microbiology group. Act as Lead Investigator to coordinate and manage the investigation of non-conformance's from initiation to closure. Provide scientific support for changes to test methodologies/ equipment. Provide supervision, coaching and guidance to technical staff.  Participate in hiring and other administrative activities for the department as required. 

Key Accountabilities

Supervise microbiological testing of samples such as raw materials, in process & finished products, the site’s environmental and utility system monitoring programs, aseptic broth simulation studies and validation of sterilization processes:

  • Day-to-day organization and planning to ensure efficient and effective testing of samples and anticipate to surges of work load.
  • Responsible for ensuring all testing materials, stock cultures and resources are planned, equipment and lab areas are maintained to support testing demands.

Responsible for review and approval of testing records and ensure documentations meet GMP, compendial and company standards procedures:

  • Maintain quality and compliance procedures so that microbiology testing procedures and documentation all meet GMP and compendial standards, and staff are appropriately trained in relevant procedures.
  • Responsible for review and approval of study protocols, data summaries, microbiological investigations and associated reports. Utilization and support of data management/release systems.

Responsible for maintaining departmental testing records ensuring all staff follow quality and compliance procedures:

  • Provide coaching and guidance to direct reports. Responsible for maintenance of the lab training program and records.  Responsible for administration activities and support hiring process of union staff, as required.
  • Troubleshoot laboratory test problems, and develop and update laboratory procedures/instrumentation taking into consideration progressive facility or equipment improvements, efficiency enhancements and updates in regulations. Provide methods validation support for changes to test methodologies or test transfers.

Act as Lead Investigator to coordinate and manage the investigation of non-conformances from initiation to closure to:

  • ensure all appropriate subject matter experts are involved and contribute to the investigation strategy.
  • liaise with their respective QO rep to provide a draft and final investigation report and supporting documentation.
  • identify root cause and ensure appropriate corrective/preventative actions are implemented.
  • review and approval final investigation report.

Education and Experience:

  • Min Bachelors' degree (B.Sc. or M.Sc, preferred) in Microbiology or closely-related discipline

  • Minimum of five (5) years relevant experience in an Industrial Microbiology laboratory with a high volume, rapid turnaround sample throughout.
  • In depth knowledge of QC microbiology techniques and compendial standards including but not limited to sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and growth promotion.
  • Experience managing a team.
  • Knowledge of analytical method development, test transfer, and method validation.
  • Knowledge of the failure investigation management system and change management system.

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.

Applications received after the official close date will be reviewed on an individual basis.

NOTE: Internal applicants are required to notify their manager of their application.

Sanofi, Empowering Life

 #GD-SP          

 #LI-SP

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.

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