As an Engineering Compliance Lead, you will play a critical role in ensuring Engineering & Maintenance operations remain compliant, inspection-ready, and aligned with quality and regulatory requirements. You will lead compliance activities across the department, drive continuous improvement initiatives, and partner with Quality and Engineering teams to strengthen quality systems, reduce deviations, and support reliable manufacturing operations.
We deliver billions of healthcare solutions to people every year, thanks to the expertise and dedication of our Manufacturing & Supply teams. By joining Sanofi, you will help ensure our facilities, systems, and processes operate to the highest standards of quality, reliability, and compliance, enabling us to bring medicines and vaccines to patients around the world.
Lead compliance activities within the Engineering & Maintenance function, ensuring effective management of quality system requirements and inspection readiness.
Drive timely completion of deviations, CAPAs, change controls, periodic reviews, and other quality management system activities.
Lead and support investigations, root cause analyses, and corrective actions to reduce recurring deviations and improve operational performance.
Coordinate preparation and support for internal audits, regulatory inspections, and external audits, ensuring effective responses and follow-up actions.
Monitor compliance metrics and identify opportunities to strengthen quality performance, reliability, and continuous improvement.
Collaborate with Quality, Manufacturing, Validation, and Engineering teams to ensure alignment with GMP and regulatory requirements.
Review engineering procedures, standards, and documentation to ensure accuracy, effectiveness, and compliance with global and local requirements.
Support training programs and capability development to strengthen compliance awareness and quality culture across the department.
Provide compliance guidance to Engineering leadership and support achievement of departmental objectives.
Experience in engineering, maintenance, quality, compliance, or related functions within a regulated manufacturing environment.
Strong knowledge of GMP, GDP, GxP, and quality management systems.
Experience managing deviations, investigations, CAPAs, change controls, and audit or inspection activities.
Strong analytical and problem-solving skills with the ability to conduct effective root cause investigations.
Excellent technical writing, communication, and stakeholder management skills.
Ability to work cross-functionally and influence continuous improvement initiatives.
Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
Proficiency in written and spoken English.
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.
Work in a highly regulated biologics manufacturing environment with exposure to global quality and engineering standards.
Partner with diverse teams to drive continuous improvement and operational excellence.
Contribute directly to maintaining quality, reliability, and patient supply through strong compliance leadership.
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!
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
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