Batch Release Lead Qualified Person

Sanofi Group; Waterford; Hybrid; EUR 73,000 - 98,000; Full time

Job summary

Sanofi Waterford seeks a Batch Release Lead Qualified Person to oversee steri le product release and ensure cGMP compliance. The role reports to the Head of Quality Lyo APU and requires hands-on batch certification, quality document review, and cross-team collaboration.

The candidate will mentor QA specialists, lead quality-improvement projects, and ensure timely releases while maintaining high safety standards in a 3 days onsite, 2 days remote per week pattern.

Qualifications

• You've worked as a Qualified Person certifying and releasing batches on a manufacturing license
• Familiar with regulatory requirements for sterile manufacturing including Annex 1
• Strong communicator who can influence across teams and deliver quality outcomes
• Fluent English and Ireland-based qualification meeting eligibility for Qualified Person status

Responsibilities

• Make sure all products released from the site meet quality and safety standards
• Review and sign off on quality documents to confirm standards
• Collaborate with other teams to resolve quality issues and close actions
• Investigate product issues thoroughly and ensure full resolution before release
• Follow safety procedures and raise safety concerns when needed
• Lead projects to improve quality processes across the site
• Mentor and support quality team members to grow their skills

Skills

Qualified Person

Regulatory knowledge

Communication skills

Sterile manufacturing

English fluency

Education

Master's degree or Pharmacy qualification

Job description

Job Title: Batch Release Lead Qualified Person

Location: Waterford, Ireland

Working Pattern: 3 days onsite, 2 days remote per week

About This Job

As Qualified Person within our Quality Lyo APU team, you'll play a critical role in ensuring that sterile pharmaceutical products are manufactured and released in full compliance with cGMP regulations. Reporting directly to the Head of Quality Lyo APU, you'll provide expert oversight of quality systems, lead improvement initiatives, mentor QA specialists, and ensure timely batch certification and release. This is an opportunity to be instrumental in shaping best practices at our award-winning Waterford site as we continue to grow and expand our capabilities. Ready to get started?

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

• Make sure all products released from the site meet strict quality and safety standards before they reach patients
• Review and sign off on quality documents to confirm everything meets required standards
• Work closely with other teams to resolve quality issues and close out actions in a timely manner
• Investigate any product issues thoroughly, making sure they're fully resolved before a product is released
• Follow all safety procedures carefully and speak up if you notice any safety concerns
• Lead projects aimed at improving how quality processes work across the site
• Support and guide quality team members, helping them grow their skills and expertise

About You

• You've worked as a Qualified Person, certifying and releasing batches on a manufacturing license - ideally within sterile product manufacturing
• You're familiar with current regulatory requirements for sterile manufacturing, including Annex 1, and you stay up to date through ongoing professional development
• You're a strong communicator who can influence others across teams and are genuinely results-driven, following through until quality outcomes are achieved
• You hold a Master's degree or Pharmacy qualification that meets the eligibility criteria for Qualified Person status (Ireland-based qualification or UK equivalent)
• You're fluent in English
• You're comfortable working on-site with flexible days based on production schedules, and you're based in Ireland

Why Choose Us

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale.
• 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.
• Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.
• Be part of world-first initiatives like our Modulus factory, smart factories, and AI-driven supply chain solutions.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.

Pursue

Pursue Progress. Discover Extraordinary.

Join Sanofi

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.

Equal Opportunities

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.

We are proud to be a Disability Confident Employer , committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.

If you have a disability and require adjustments for the interview process, please email us at . We are dedicated to ensuring an inclusive and supportive experience for all applicants.

Progress and Discovery

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.

Salary

The salary range for this position is :73 200,00 - 97 600. 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.

Company Description

We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting or via our movie We are Sanofi ( a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.