Job Description

Reference No. R2657424 Position Title: Manager, Stability Department: QC Stability 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. Mission: The Stability Manager will prepare and execute complaint stability programs for Routine, and Special Study (including change control, clinical, non-clinical and intermediate studies) categories. The incumbent will facilitate all aspects of stability study lifecycles to ensure compliance and timely execution and closure. A contribution to quality-based initiatives, at both a documentation and process level, is expected. The Stability Manager will prepare and execute stability data for colleagues in Quality Control, Industrial Operations and other departments to ensure the submission of new product licenses and control the necessary changes to licensed/marketed products. Key Accountabilities: Routine and Special Studies:

• Prepare and execute routine, initial and special studies; prepare appropriate documentation (e.g. forecasts, protocols, reports).
• Manage stability lifecycles to ensure compliance and timely execution and completion (i.e. preparation of interim/final documentation, distribution of samples, organization /compilation /verification of data and determination of study conclusions); ensure a smooth transition through each phase and provide resolution to scheduling conflicts (i.e. test schedules), as well as compliance issues.

Regulatory Submission:

• Support the timely submission of product license applications, license renewals, license amendments and response to questions, in conjunction with Quality Operations and Regulatory Affairs, through the development and execution of stability strategies and data analysis/interpretation.

Biological Product Deviation Reports:

• Support investigations related to deviation reports (e.g. biological product deviation reports to CBER are prepared and sent for filing in a timely manner, and follow ups are performed.

Compliance and Performance:

• Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety.
• Execute changes of stability protocols to ensure change controls are completed in time and support the update of site procedures to new and revised Global Quality Directives (GQDs).
• Provide support to regulatory inspections, audits, and ensure responses and CAPA actions are completed by the designated target date.
• Support the investigations and closure of quality incidents/deviations, as well as the completion of Corrective and Preventative Actions (CAPA) and subsequent follow-up monitoring/ trending (as applicable).

Education and Experience:

• Bachelor of Science Degree, with specialization in Biology, Biochemistry, Microbiology, Immunology and Chemistry.
• At least 3 to 5 years pharmaceutical experience with elated Quality experience in Stability Programs/processes and the associated regulatory requirements.

Key technical competencies and soft skills:

• Excellent report writing analytical and communication/interpersonal skills as well as strong organizational and leadership/teamwork abilities.
• Knowledge of cGMP (US, Canada, Japan, China and Europe) preferred.
• Experience on project teams (as project member and /or leader), multiple project management, as well as an understanding of vaccine manufacturing processes and test methodologies is preferred.

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. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. 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.