Lead, Contamination Control & Sterility Assurance

Location

Framingham, MA

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.

Our Team

The purpose of this position is to take the lead for CMC-Pharma ensuring that all platforms have proper contamination control and sterility assurance practices. This position coaches and mentors all R&D sites overseeing the contamination control strategy (CCS) and facilitating the sterile network. Diagnoses and recommend action and decisions during microbial investigations and product impact assessments.

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

• Subject matter expert (SME) in Contamination Control & Sterility Assurance. Demonstrated understanding of contamination control and sterility assurance regulatory requirements and industry best practices.
• In-depth knowledge of quality regulations and guidelines applicable to R&D pharmaceutical activities.
• Excellent interpersonal, communication, and facilitation skills since this position requires frequent direct interaction with and appreciation for the relationship side of our R&D partners, CMOs, CLOs.
• Participate in regulatory inspections at the CMOs and CTLs.
• Monitor the risk profile of external partners and subcontractors ensuring that proper mitigation is in place by providing current regulatory guidance or requirements (i.e., ICH Q2, Q7, Q9, Annex 1, Annex 13).
• Participate in external audits, self-inspections, and participate in due diligences activities for prospective alliances, partnerships or acquisitions.
• Able to identify, escalate, and manage quality alerts and other critical investigations. To rapidly and properly assess SISPQ.
• This position is critical to develop and lead a first-class Quality support team for R&D operations from preclinical to submission to launch Sanofi’s gene therapy portfolio.

About You

• Master's degree in science or engineering with 8 years of relevant experience, OR bachelor's degree in science or engineering with 10 years of relevant experience
• Extensive experience in the pharmaceutical industry with expertise in cGMP, ICH, FDA, and EMA regulations, particularly in microbial control and sterile product manufacturing
• Proven track record in analytical testing and identification of microorganisms, with a strong understanding of microbial prevention and detection techniques
• Excellent technical writing and verbal communication skills, with the ability to influence stakeholders across various departments (Development, Manufacturing, Engineering, Digital, Quality, Procurement, and Regulatory Affairs)
• Demonstrated project management experience in complex, international environments, showcasing leadership in multi-cultural teams
• Thorough understanding of facility classification maintenance and sterile product manufacturing processes.

Remote Working and Travel

Up to 40% Remote working and Responsible for travel to various contract facility sites as needed for CMO relationship/production management and/or Person in Plant, 20% travel, Domestic and International.

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.

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, 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 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, gender identity, protected veteran status or other characteristics protected by law.