Position Title: Production Compliance Manager - Vaccines Fixed-Term - Contract End Date: April 4, 2025 Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 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 DT/PPD Manufacturing department. 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. 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. Work with Platform Leaders to identify and develop process improvements to remediate risks. develop assessment of risk to product, process and other stages. 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 (10%): 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. 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. Act as a backup to the shift manager for vacation coverage and other. Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act. Collaborate with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) to ensure deviation investigations are closed according to targeted timelines. Production area environment. Office area environment 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. 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. Stretch – try new things, take calculated risks, look for ways to apply learning Think Sanofi first – share information openly, think of what is best outside the team & function, help colleagues across the organization. Watch our and check out our Diversity, Equity and Inclusion actions at ! Sanofi is an equal opportunity employer committed to diversity and inclusion. Accommodations for persons with disabilities required during the recruitment process are available upon request. Follow Sanofi on Twitter: and on LinkedIn: #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. #