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    Sanofi Group
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Who We Are:The Head of Sterility Assurance Center of Excellence (SA CoE) will have global responsibility to lead the development of a Sterility Assurance strategy to harmonize on best practices, improve efficiency and drive continuous improvement opportunities across the Sanofi Pasteur (SP) network. He or she must have a strong and strategic vision for a world class sterility assurance program. This must be achieved in collaboration with Sanofi Pasteur sites, cross functional departments and Sanofi Global Business Units. The Head of SA CoE will analyze, propose and oversee initiatives that support driving to achieve this vision as well as ensuring that all current and future regulatory requirements are incorporated into our Quality System.This will be done by utilizing of CoE Office tools to develop a SA CoE Roadmap with prioritized Task Forces emphasizing productivity gains, on-time completion of milestones and achievement of a stronger compliance standing.Where Are We:Incumbent can be located “Remote” anywhere on the E ast coast of the United States if located in the US.Job Highlights:Provide leadership, guidance and direction around technical aspects of sterile manufacturing/, including aseptic operations, environmental monitoring, aseptic process simulation (APS) microbial identification and testing, cleaning and disinfection, and operator qualification.Establish and lead a Sterility Assurance Center of Excellence consisting of experts from relevant functions in IA to assist with the assessment, development and implementation of Sterility Assurance Programs and continuous improvement activities across SP sites.Provide Quality oversight and input to projects for new facilities or equipment for aseptic operations and deployment of new technologies.Provide leadership for the successful collaboration between Digital, Quality and technical functions to achieve desired functionality, compliance and productivity for new solutions in Sterility Assurance and Environmental Monitoring areas.Interact with external bodies to broaden and bring knowledge and awareness of industry practices to SP and monitor the regulatory and technological developments in the areas of Sterility Assurance to continually improve/evolve the SP sterility program.Represent Sanofi Pasteur in the Sanofi Sterility Assurance and Contamination Control Community of Practice to provide a vaccine perspective, contribute to technical discussion and cascade corporate initiatives to SP sitesBasic QualificationsMaster’s degree in microbiology, Pharmaceutical Science or related biological subject (Ph.D. preferred)10 years of industrial experience in the Pharmaceutical/Biotech Sterile Manufacturing.Strong Quality mindset with experience in managing compliance and Health Authority regulations. Prior experience in Pharmaceutical Industry Committees or Working Groups is an advantage.Significant expertise and understanding of technical aspects of sterile manufacturing, including aseptic processes, aseptic process simulation (APS), microbiological testing and environmental monitoring.A strong analytical and problem-solving ability is essential, along with knowledge of quality and technical regulations in a GMP environment.Ability to establish and maintain strong and effective working relationships with key stakeholders, and foster collaboration across the sites is essential, requiring excellent written and verbal communication and presentation skills.Experience communicating with senior management and regulatory agencies is a requirement.Terms Of Employment:Approximately 15% travel for site visitsThis role will be considered a remote role within the USSanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SP#LI-SPAt 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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