Manager, Lead Investigator(Bulk Manufacturing Vaccines)
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Manager, Lead Investigator, Deviation (Bulk Manufacturing Vaccines)
Reference #: 2480215
Location: Toronto, Ontario
Department: Bulk Manufacturing
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.
The Manager, Lead Investigator, Deviation (Bulk Manufacturing Vaccines) is a detail oriented and results driven individual with a strong understanding of biologics manufacturing, cGMPs, root cause analysis and possesses exceptional technical writing skills. The incumbent is responsible for leading Deviation Investigations within the Bulk Manufacturing department. Reporting to the Bulk Deviations Team Lead, the following are the key responsibilities:
Responsible for all critical, major, minor deviations associated with the Platform:
- Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate.
- Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, SMEs.
- Perform Root Cause Analysis by conducting process walks (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.
- Identify expertise required for the investigation (MTech, Technical Services, QC, QOVS, QOSA, etc.).
- Identify, co-ordinate and manage contributions from other departments.
- Participate in Focus Factory Support teams for planning and execution of investigations.
- Review and provide guidance on reports prepared by technical staff.
- Prepare manufacturing investigations to support other functional areas as requested.
Develop appropriate corrective and preventive actions:
- In collaboration with platform management and other stakeholders, develop appropriate CAPAs to address the root cause.
- Initiate CAPAs in the Quality System as required.
- Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders.
- Work with Platform Leaders to identify and develop process improvements to remediate risks.
Write and manage associated documentation, actions, and timelines:
- Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise and comprehensive.
- Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines.
- Ensure actions are assigned to the appropriate individuals and completed to meet timelines.
- Prepare for regulatory inspections by drafting investigation briefing packages as applicable.
Develop Investigation cases to present at Governance boards:
- Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.
- Present to Material Review Board as required.
- Utilize the Deviation Review Board Governance as required.
- Present and defend investigations in Regulatory inspections and other audits.
- Preferred MSc. (Min B.Sc.) in Microbiology, Biochemistry, Engineering, Biotechnology or related area
- Minimum of four (4) years of experience in pharma/biologics commercial manufacturing, manufacturing technology, or quality
- High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment.
- Experience in regulatory inspections.
- Good problem solving skills and documentation and technical writing skills.
- Six-sigma or other root cause training and experience.
- Experience with multiple software programs such as SAP/ERP, Trackwise, and/or regulatory compliance software
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
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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