Sterility Assurance and Microbiology Global Expert

Job title: Sterility Assurance and Microbiology Global Expert

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Your job as Sterility Assurance and Microbiology Global Expert within our Quality Control Microbiology team, will be to manage the global expertise for Sterility Assurance & Microbiology including development of the Community of Practices for Sterility Assurance and Microbiology. You will also act as a key contributor to the Sterility Assurance & Microbiology team by providing strategic view, technical expertise and troubleshooting support to all Sanofi business units.

The Sterility Assurance & Microbiology team have global responsibility to lead the development of a Sterility Assurance and Microbiology policies to harmonize on compliant best practices, improve efficiency and drive continuous improvement opportunities across all Sanofi business units.

The Sterility Assurance & Microbiology team 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Provide leadership, guidance, and direction around technical aspects of drug and sterile manufacturing, including aseptic operations, contamination control strategy, environmental monitoring, aseptic process simulation (APS) microbial identification and testing, cleaning and disinfection, and operator qualification.

• Develop and maintain the Sanofi standards and supporting documents of expertise ensuring the standards/strategies are compliant and up to date with the regulations regarding sterility assurance and microbiology aspects.

• Establish and lead approaches with experts from across Sanofi units to assist with the assessment, development and implementation of Sterility Assurance and Microbiology Programs and continuous improvement activities across sites

• Provide input to projects for new facilities or equipment, new launch product and deployment of new technologies

• Provide support to Sanofi sites to prepare and support key regulatory inspections

• Provide support for the successful collaboration between Digital, Quality and technical functions to achieve desired functionality, compliance and productivity for new solutions in Sterility Assurance and Microbiology areas

• Leads and/or participates in cross-functional teams at all levels to execute contamination control objectives

• Interact with external bodies to broaden and bring knowledge and awareness of industry practices to Sanofi and monitor the regulatory and technological developments in the areas of Sterility Assurance and Microbiology to continually improve/evolve the program for Sanofi

About You

Basic Qualifications

• BS or MS in Microbiology, Biochemistry, Pharmaceutical Sciences, or related field. Microbiology is strongly preferred

• Minimum of 15 years of industrial experience in Pharmaceutical/Biotech Sterile Manufacturing is required

• Strong Quality mindset with experience in managing compliance and Health Authority regulations.

• Strong knowledge of Contamination Control Strategy and Quality Risk Management principles

• Significant expertise and understanding of technical aspects of sterile manufacturing, including aseptic processes, aseptic process simulation (APS), disinfection/decontamination/sterilization, 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

• Proven ability to successfully lead cross-functional teams

Preferred Qualifications

• BS or MS in Microbiology is strongly preferred

• Prior experience in Pharmaceutical Industry Committees or Working Groups is an advantage

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.