Job Title: Head of Sterility Assurance & Microbiology Control
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Location: Ocoyoacac Plant, Mexico
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Work model: On-site
About the Job
As the Sterility Assurance and Microbiology Control Head within our M&S Vaccines Quality team, you will lead the development and implementation of comprehensive sterility assurance and microbiological control programs, ensuring regulatory compliance and adherence to pharmaceutical industry best practices. You will be responsible for managing a specialized team, driving continuous improvement, and ensuring our aseptic processes meet the highest quality standards. Ready to get started? . Ready to get started?
Join a global network that drives how Sanofi delivers its products, seamlessly, intentionally, and at scale. In M&S, you will help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Key Responsibilities:
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Develop and implement comprehensive sterility assurance and microbiological control programs (environment, water, steam, aseptic processes, cleaning validation, etc.), aligned with the organization's strategy and objectives.
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Ensure regulatory compliance of products and processes with local (NOM-059) and global requirements, as well as Sanofi's quality standards.
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Manage microbiological risks, ensuring their identification, monitoring, and effective mitigation; supervise critical production activities and aseptic best practices.
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Oversee the validation and qualification of methods, equipment, and environments in conjunction with the Qualification and Validation team, ensuring sterility control.
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Monitor KPIs and metrics, analyze trends, lead critical events, and define corrective and preventive actions (CAPA) in response to deviations.
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Lead and develop the sterility assurance and microbiology team, including hiring, training, coaching, and performance evaluation; ensure regular presence (25% of the time) on the plant floor.
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Prepare and lead regulatory inspections, interact with external bodies and Global Quality, and provide technical expertise to other functions to drive continuous improvement and innovation.
About You
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Experience: Solid track record as a manager or leader in the pharmaceutical or chemical industry, with a focus on sterility assurance, microbiology, and aseptic processes.
Experience in team management, leading regulatory inspections, and handling quality management systems.
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Soft and technical skills:
Knowledge of Microbiology and Aseptic Processes
Regulatory Knowledge (NOM-059, global GMP)
Environmental and Microbiological Monitoring
Validation and Qualification
Quality Risk Management Team Leadership
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Education: Bachelor's degree in Chemical Pharmaceutical Biology (QFB), Pharmaceutical Engineering (IF), Chemical Engineering (IQ), Industrial Pharmaceutical Chemistry (QFI), or related fields.
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Languages: Advanced English (essential for global and regulatory collaboration).
Why Choose Us
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Bring the miracles of science to life alongside a supportive and future-focused team.
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Discover endless opportunities to develop your talent and advance your career, whether through a promotion or a lateral move, locally or internationally.
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Enjoy a well-designed and thoughtful benefits package that recognizes your contribution and boosts your impact.
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Shape the future of medicine and vaccine distribution with cutting-edge technology, ensuring seamless launches and a resilient global supply chain.
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Drive industry-leading performance by leveraging digital innovation, data, and artificial intelligence, with speed and at scale.
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Transform lives around the world by delivering life-changing treatments anywhere, anytime.
Pursue Progress. Discover the Extraordinary.
Join Sanofi and enter a new era of science - where your growth can be as transformative as the work we do. We invest in you to go further, think faster, and do what has never been done before.
You will help push boundaries, challenge conventions, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover the Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity, Equity, and Inclusion actions at sanofi.com!
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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!