Ready to engineer precision in the world of biotech? Join our client's cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow's breakthroughs.

Hobson Prior is seeking a QC Validation Manager to join a dynamic team on a 12-month fixed-term contract. In this role, you will oversee the validation and transfer of testing methods for gene therapy products, ensuring compliance with EU and FDA GMP standards. You will also manage the lifecycle of analytical methods, equipment, and materials while supporting both Irish and UK sites. Occasional travel to the Irish site will be required. This position can either be based in London with occasional travel to Ireland, or based in Shannon, Ireland with occasional travel to United Kingdom.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop and validate new and existing testing methods for gene therapy products.
• Act as the go-to expert for managing analytical methods, equipment, and materials.
• Oversee projects related to test method implementation to meet deadlines for product launches.
• Ensure all testing methods comply with regulatory and data integrity standards.
• Manage external testing activities to ensure they meet GMP requirements.
• Provide training on new technologies and methods introduced to the facility.
• Regularly assess analytical methods to ensure they are effective and compliant.
• Maintain and update quality management systems and documentation.
• Track and achieve key performance indicators (KPIs) and project objectives.
• Ensure timely and compliant completion of team training and GMP documentation.

Key Skills and Requirements:

• A degree in a health or science-related field, or equivalent experience in a regulated industry.
• Strong background in validation within the pharmaceutical or similar regulated sector.
• Experience managing a team and delivering projects on time.
• Knowledge of EU and FDA regulations, GMP, and other relevant compliance standards.
• Ability to handle multiple projects simultaneously in a fast-paced environment.
• Familiarity with lean manufacturing, Six Sigma, or similar methodologies is a plus.

For more information, please contact Billy O'Brien.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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