Are you passionate about bringing ground-breaking gene therapies to life?
Do you thrive on leading validation projects that ensure scientific excellence and regulatory compliance?
Are you ready to take ownership of analytical innovation within world-class laboratories equipped with the latest biomanufacturing technology?
If so, this opportunity could be the next defining step in your career.
Your Mission
As a QC Validation Manager, you’ll play a central role in developing, validating, and transferring novel and established analytical methods used to test pioneering gene therapy products and their materials. You’ll ensure that every assay, instrument, and process supporting QC operations meets the highest standards of EU and FDA GMP compliance — helping to deliver transformative treatments safely and efficiently.
This role offers a unique blend of leadership, technical depth, and innovation within a dynamic environment dedicated to scientific excellence.
What You’ll Do
- Lead the development, validation, and transfer of analytical test methods for current and next-generation gene therapy products.
- Act as a subject matter expert for the life cycle management of assays, materials, and QC laboratory equipment.
- Design, manage, and execute qualification and validation projects, ensuring all documentation meets GMP and data integrity expectations.
- Oversee the implementation of analytical methods to support seamless product launches and new technology introductions.
- Ensure external testing activities and collaborations align with GMP standards and compliance frameworks.
- Maintain effective communication with stakeholders across Quality, Manufacturing, and Development teams.
- Lead and support training initiatives, ensuring QC teams are equipped to operate new methods and technologies confidently.
- Drive continuous improvement by monitoring analytical method performance and ensuring optimal operation.
- Support Quality Management System (QMS) activities, including CAPAs, deviations, and change control processes.
- Uphold a culture of quality, safety, and compliance, ensuring the highest standards are met at all times.
What You’ll Bring
- A degree in Life Sciences, Biotechnology, or a related field, with extensive experience in the pharmaceutical or biopharmaceutical industry.
- Demonstrated expertise in analytical method validation within GMP-regulated environments (ATMPs or gene therapy preferred).
- Proven leadership skills and experience managing teams and delivering projects to completion.
- Comprehensive understanding of EU and FDA GMP requirements, particularly for analytical and stability testing.
- Strong communication, organizational, and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced, evolving environment.
- Proficiency in Microsoft Office and relevant laboratory IT systems.
- Willingness to travel between UK and Ireland sites as needed.
Key Competencies
- Technical Mastery: Deep expertise in analytical method validation, equipment qualification, and GMP lab operations.
- Leadership: Inspires and develops others; promotes collaboration and accountability.
- Problem Solving: Analytical and proactive, with a focus on root cause and continuous improvement.
- Project Management: Structured, deadline-driven, and results-focused.
- Quality Mindset: Passionate about accuracy, data integrity, and regulatory excellence.
- Professionalism: Calm, confident, and respectful under pressure.
Why Join Us
Step into a role where science, technology, and purpose converge. You’ll work within cutting-edge facilities equipped to support the most advanced analytical methods in gene therapy development. This is a chance to lead meaningful validation projects that directly contribute to delivering life-changing therapies to patients around the world.
If you’re motivated by innovation, collaboration, and the pursuit of excellence — we’d love to hear from you.
