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.

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.

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!

The salary range for this position is :€54 800,00 - €73 067

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.