Production Compliance Manager

We deliver 4.3 billion healthcare solutions annually, thanks to the meticulous planning and attention to detail of our Manufacturing & Supply teams. With your talent and ambition, we can further protect people from infectious diseases and bring hope to patients and their families. As the Production Compliance Manager in our Strategy, Project, and Process Team, you will lead Deviation Investigations, ensure Shop Floor compliance, and execute continuous improvement initiatives within the B100 Manufacturing department.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Lead and manage all critical, major, and minor deviation investigations on the platform, collaborating with Quality Operations, Manufacturing, and Subject Matter Experts (SMEs) to determine scope, develop strategies, perform root cause analysis, and ensure comprehensive and timely documentation and closure of investigations.
• Coordinate and manage contributions from various departments, participate in support team meetings, provide guidance on technical reports, and ensure actions are assigned and completed within targeted timelines to support continuous improvement initiatives.
• Collaborate with platform management and stakeholders to develop and initiate Corrective and Preventive Actions (CAPAs) in the Quality System, support manufacturing staff in updating GMP documents, and review CAPAs for recurring issues, escalating as necessary.
• Work with Platform Leaders to identify and implement process improvements to mitigate risks and ensure continuous improvement.
• Assess risks with SMEs and QO experts, prepare for regulatory inspections, and support area managers during inspections and audits.
• Responsible for Shop Floor Compliance within the Platform
• Continuous Improvement and GMP Documentation Review within the Platform

About you:

• Minimum bachelor's degree in Microbiology, Biochemistry, Engineering, Biotechnology, or a related science.
• 2-4 years of relevant experience in Commercial Manufacturing, Manufacturing Technology, or Quality Operations preferred.
• Strong knowledge of cGMPs in pharmaceuticals/biological manufacturing and experience in regulatory inspections.
• Excellent problem-solving, communication, and organizational skills, with strong technical writing abilities.
• Six Sigma or other root cause training and experience.
• Proficient in software programs such as SAP, Trackwise, Word, Outlook, Visio, and PowerPoint.

Hours of Work:

Monday to Friday 8:00a.m.-4:00p.m.

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.