Reference No. R2580130 Position Title: Production Compliance Manager – Vaccine Department: DTPPD Bulk 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. Summary of Purpose: The Production Compliance Manager 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, ensuring Shop Floor compliance and execution of continuous improvement initiatives as a result of Deviation Investigations within the DTPPD Manufacturing department. Key Accountabilities: Responsible for all critical, major and minor deviations associated with the Platform: Acts as a core member of the B90 Bulk Autonomous Production Team (APT), collaborating with a cross-functional team to achieve the APT’s objectives. Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor. Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs. Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (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 Autonomous Production Team (APT) support team meetings 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. 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. Develop appropriate corrective and preventive actions: In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause. Initiate CAPAs in the Quality System as required. Support manufacturing staff on updating GMP documents arising from CAPAs. 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. 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. Utilize the Deviation Review Board Governance as required. Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable. Present and defend investigations and provide support to the area manager for process / procedure topics during Regulatory inspections and other audits. Responsible for Shop Floor Compliance within the Platform: Lead and manage Data Integrity activities, initiatives and continuous improvements within the Platform in collaboration with APT Support teams and QOVS. Perform Shop Floor Production Walkthroughs (GEMBA) to identify compliance gaps. Track and develop action plan to address gaps, as required. Continuous Improvement and GMP Documentation Review within the Platform: Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Shop Floor operations. Participate in special projects for production process improvement projects to meet GMP requirements and address inspection observations. Provides metrics and other reports as required. Support GMP Documentation review (BPRs, logbooks, etc.) as required. Be a subject matter expert on process flow and area procedures. Act as a backup to the shift manager for vacation coverage and other. Education and Experience: Minimum BSc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science or higher Level Education A minimum of four (4) years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment Experience in regulatory inspections Good problem solving skills Must possess excellent communication and organization skills. Excellent technical writing skills Six-sigma or other root cause training and experience Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint Competencies: Strive for results Cooperate transversally Act for change Commit to customers 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. 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.