Manufacturing Operations Manager

Manufacturing Operations Manager

Location: Waterford

Job Type: Full-time (5 days on-site)

About the Opportunity

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.

Reporting directly to the Head of Product Supply, and as a key leader within the Product Supply Autonomous Production Unit (APU) at Sanofi Waterford, you will play a pivotal role in ensuring the reliable supply of mAbs & Lyo products to patients worldwide. This position involves day-to-day leadership of operational teams, ensuring timely and compliant production while driving performance, compliance, and continuous improvement.

You will oversee critical manufacturing processes related to vial & syringe inspection, assembly & Packaging, working closely with cross-functional stakeholders in Quality, Engineering, Planning, and Technical Services to ensure seamless execution of production targets in a highly regulated GMP environment.

This is a people-focused leadership role with strong expectations around coaching, compliance, lean execution, and operational excellence.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located on Ireland’s southeast coast. Established in 2001 and now employing over 900 people, the site has seen more than €600 million in investment in advanced technology and infrastructure. Waterford supports global markets with an expanding and diverse portfolio, including biologics, medical devices, and combination products. The MAbs unit is a cornerstone of the site’s contribution to Sanofi’s portfolio, producing critical medicines for global supply.

Main responsibilities:

• Operations Leadership.
• Lead all assigned inspection, Assembly and packaging operations to ensure timely execution of batch schedules, turnaround time, and product release cycle time.
• Execute production planning in alignment with supply chain and scheduling teams to meet demand.
• Manage operational readiness for new products and support technology transfer and process validation activities.
• Ensure effective shift handovers and communication across teams.
• Drive execution of KPIs related to throughput, downtime, deviations, and productivity.
• Compliance and Quality
• Ensure all operations are executed in full compliance with current Good Manufacturing Practices (cGMP), Safety, Environmental, and Sanofi Quality standards.
• Monitor GMP compliance through deviation management, audit support, SOP reviews, and batch documentation reviews.
• Ensure procedures are current, accurate, and effectively implemented by the team.
• Support and lead investigations (deviations, CAPAs), working closely with QA, TS, and other stakeholders.
• Promote a culture of continuous quality improvement and right-first-time execution.
• People Management and Development.
• Lead, coach, and develop a team of operators, leads, and/or supervisors across the mAbs operations.
• Ensure all employees are adequately trained for their roles, including technical and GMP training.
• Conduct performance evaluations, develop talent, and implement succession planning.
• Foster a culture of engagement, ownership, and collaboration within the team.
• Actively participate in recruitment, onboarding, and workforce planning processes.
• Continuous Improvement.
• Develop and implement a site-level continuous improvement strategy focused on reducing Cost of Goods (COGs), improving efficiency, and simplifying processes.
• Lead or support lean initiatives, kaizen events, and problem-solving teams.
• Implement metrics and visual management tools to support performance monitoring and daily accountability.
• Promote a proactive approach to problem-solving and operational excellence.
• Health, Safety & Environment (HSE).
• Promote and maintain a zero-incident safety culture.
• Ensure that all operations and employees follow HSE policies and procedures.
• Conduct routine safety audits and risk assessments within the production area.
• Drive compliance with safety training and environmental standards.

About You

To excel in this role, you will need:

• Higher-level diploma/degree in a relevant discipline (e.g., Science, Engineering, or related technical field).
• Minimum 2 years’ experience in an Operations Manager or equivalent leadership role.
• At least 1 year of experience working in a pharmaceutical GMP manufacturing environment.
• Strong technical knowledge of inspection/ packaging , or similar manufacturing technologies.
• Proven ability to lead operational teams in a regulated manufacturing setting.
• In-depth knowledge of cGMP, regulatory expectations, and batch documentation.
• Strong interpersonal and communication skills with an ability to lead through influence.
• Good problem-solving, analytical thinking, and decision-making abilities.
• Demonstrated ability to influence site-level KPIs through leadership and improvement activities.
• Understanding of Health & Safety and legal requirements for manufacturing operations.

Desirable

• Exposure to Lean Six Sigma or similar operational excellence methodologies.
• Experience supporting regulatory inspections (FDA, HPRA, etc.).

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

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at Sanofi.

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!