Manager, Change Management

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City : Toronto

Category : Quality, R&D

Industry : Pharmaceutical

Employer : Sanofi

Manager, Change Management

Reference #: R2503204

Department: GMP Compliance

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.

Mission:

The incumbent is responsible for managing changes within the Change Management Quality System, a major quality system that provides the forum and controls for maintaining compliance to regulatory requirements and current and pending licenses. In addition, this system provides the forum for continuous improvement and prospective change management of our validated facilities, equipment, utilities and processes. It is a global system that operates across all Sanofi Pasteur sites utilizing the same process and tools.

Key Accountabilities:

  • Manage the Change Control Process by providing support and guidance to Industrial Operations throughout the change lifecycle as well as by co-chairing the Site Change Control Committee, trending metrics and developing and delivering training.
  • Manage Change Controls which involves performing quality evaluation of all changes; making decisions to approve change controls for execution; support implementation and reject changes; release changes for use in a GMP environment upon closure of CCRs; and tracking the progress of all open change controls.
  • Support both site and global process improvement initiatives to the process and tool; creating and providing appropriate metrics to monitor status and timelines of change controls; providing support and guidance throughout the process; providing subject matter expertise during external/internal regulatory inspections/audits as well as developing and delivering training in support of the process/tool.
  • Identify and facilitate process improvement initiatives for the Change Management process and tool to ensure adherence to regulations and improve efficiency.
  • Work within the policies and regulations as required by the company, regulatory agencies and under the Occupational Health and Safety Act.

Education and Experience:

  • Min. Bachelors Degree in Sciences (Biology/Microbiology/Chemistry or related field)
  • Min. seven (7) years of experience and understanding of manufacturing/testing environments in the pharmaceutical Biotech Industry
  • Min. three (3) years of experience in managing Quality Systems

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

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 #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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