Batch Release Lead Qualified Person

Sanofi; Waterford; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Disability Confident Employer

Inclusive interview process

Job summary

Sanofi in Waterford, Ireland, is seeking a Batch Release Lead Qualified Person to oversee end-to-end batch certification for sterile products. The role reports to the Head of Quality Lyo APU and involves leading quality initiatives, mentoring QA specialists, and ensuring timely release of products.

You will work onsite with a 3 days in the facility and 2 days remote per week, across a dynamic site expanding its capabilities.

Qualifications

• Has worked as a Qualified Person certifying and releasing batches on a manufacturing license, ideally in sterile product manufacturing.
• Familiar with current regulatory requirements for sterile manufacturing, including Annex 1, and engages in ongoing professional development.
• Strong communication skills with ability to influence across teams and drive quality outcomes.

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, ensuring they’re fully resolved before release.
• Follow all safety procedures and speak up about safety concerns.
• Lead projects aimed at improving how quality processes work across the site.
• Support and mentor quality team members to grow their skills and expertise.

Skills

Qualified Person experience

Sterile manufacturing

Regulatory knowledge (Annex 1)

English fluency

Education

Master's degree in Pharmacy

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 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.

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 [e-mail]. We are dedicated to ensuring an inclusive and supportive experience for all applicants.