Fabrication et Approvisionnement
Là où les miracles
de la science
deviennent une réalité pour les patients

Job Title: Manufacturing Compliance Lead

Location: Waterford, Ireland

About the job

As a Compliance Leader, you play a critical operational leadership role within Lyo Operations, ensuring the compliance in the department at Sanofi is effectively maintained and enhanced.

You are accountable for cGMP & HSE compliance, training, and maintaining inspection readiness for complex aseptic systems for sterile vial filling and Lyophilisation area.

You act as the central coordination point across all functions involved for compliance. While you are not directly accountable for the performance of other departments, you are responsible for establishing and maintaining the governance framework that enables each function to meet its commitments. This includes identifying performance gaps, escalating risks, and driving corrective actions where required.

Ready to get started?

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

- Raising and management of all Quality System processes including Change Controls, Deviations, Tasks, Quality Events etc.

- Driving of all Quality Metrics for the department

- Forward review of Quality Metrics to ensure no over-dues

- Procedure effectiveness and simplification and actively contribute to continuous improvement initiative

- Ensure Training is fit for purpose and complies with all applicable legislative requirements.

- Ensure effective co-ordination and support for external and internal audits for the department.

- Perform critical / constructive review of procedures and practices.

- Identify and lead projects to make step change improvements to the departments Quality.

- Conduct duties in a safe manner and report all safety issues or concerns

- Support leadership team in achieving goals / tasks

- Attend offline department meetings and be the voice of the department.

- Actively contribute to continuous improvement initiatives utilising lean methodologies where appropriate.

- Liaise with Quality Representative to support and improve RFT in the area and Always Audit Ready.

- Complete all duties as per relevant SOPs

- Ensure compliance to cGMP at all times

About you

• Degree in Life Sciences, Engineering, Pharmacy, or a related discipline

• Minimum of 3 years’ experience in a similar or related role

• Significant experience in a biopharmaceutical or pharmaceutical manufacturing environment.

• Demonstrated experience in cross-functional coordination

• Extensive knowledge of cGMP and GDP in a regulated environment

• Specialist knowledge of training and quality systems in a regulated environment

• Excellent accuracy and attention to detail

• Excellent interpersonal skills

• Good Presentation skills

• Working knowledge of MS Office

• Effective personnel and project management skills

• Business awareness and continuous improvement techniques

• Knowledge of Lyophilisation and associated processes or biologics manufacturing processes is an advantage

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.

PursueProgress. DiscoverExtraordinary.

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.

Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.