QC Validation Manager We are looking for an ambitious and driven QC Validation Manager to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products.
What You'll Do: Lead Method Development: Spearhead the development and validation of both novel and established analytical methods for gene therapy products, driving innovation in therapeutic approaches Lifecycle Management: Oversee the complete lifecycle management of assays, equipment, materials, and in-process samples, ensuring optimal performance and compliance throughout Project Management: Be responsible for the implementation of test methods within defined timelines, enabling the seamless launch of new gene therapies Compliance Champion: Ensure all methods are compliant with EU and FDA GMP regulations, maintaining data integrity and supporting regulatory submissions External Testing Oversight: Manage and coordinate external testing activities, ensuring they align with internal quality standards and meet GMP requirements Documentation Excellence: Generate and manage qualification/validation documentation, ensuring all analytical activities are well-documented and compliant with regulatory and internal standards Cross-Functional Collaboration: Communicate effectively with stakeholders across departments, ensuring transparency and timely updates on projects Training & Development: Lead the rollout of training for new technologies and methods, empowering your team to stay ahead of the curve in gene therapy advancements What Makes You a Great Fit: Extensive experience in the validation of analytical methods within the pharmaceutical or regulated industry, with a solid understanding of ATMPs and GMP regulations You can identify issues quickly, develop innovative solutions, and inspire your team Proven ability to manage multiple complex projects, delivering them on time while maintaining a high standard of quality and compliance Deep knowledge of data integrity and good documentation practices, ensuring all processes are accurate, thorough, and fully compliant with regulatory requirements About our client: Global Impact: Work with a company that's developing cutting-edge gene therapies to address serious unmet medical needs Innovative Environment: Be part of a dynamic, forward-thinking team that embraces innovation and empowers you to make a real difference in people's lives Professional Growth: Opportunities for continuous learning and development as you work with the latest technologies and collaborate with experts across the globe Cutting-Edge Facilities: Our clients state-of-the-art manufacturing and testing facilities are designed to meet the highest global regulatory standards, giving you the tools and environment you need to succeed What We're Looking For: Degree in Human Health or Sciences, with extensive experience in the pharmaceutical or other highly regulated industries like biologics Proven experience in a QC Validation role with a strong track record of successfully managing teams and delivering high-impact projects Deep understanding of regulatory compliance, including GMP, EU and FDA requirements, and data integrity standards.
Willingness to travel between our UK and Ireland sites as required If you're ready to take your career to the next level and contribute to life-changing science, we want to hear from you!