QC Validation Manager
3 weeks ago
We are seeking a highly skilled and experienced QC Validation Manager to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products.
Lifecycle ManagementAs a QC Validation Manager, you will be responsible for overseeing the complete lifecycle management of assays, equipment, materials, and in-process samples, ensuring optimal performance and compliance throughout.
Project ManagementYou will be responsible for the implementation of test methods within defined timelines, enabling the seamless launch of new gene therapies.
Compliance ChampionEnsure all methods are compliant with EU and FDA GMP regulations, maintaining data integrity and supporting regulatory submissions.
External Testing OversightManage and coordinate external testing activities, ensuring they align with internal quality standards and meet GMP requirements.
Documentation ExcellenceGenerate and manage qualification/validation documentation, ensuring all analytical activities are well-documented and compliant with regulatory and internal standards.
Cross-Functional CollaborationCommunicate effectively with stakeholders across departments, ensuring transparency and timely updates on projects.
Training & DevelopmentLead the rollout of training for new technologies and methods, empowering your team to stay ahead of the curve in gene therapy advancements.
Key Requirements:
- Extensive experience in the validation of analytical methods within the pharmaceutical or regulated industry
- Solid understanding of ATMPs and GMP regulations
- 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
- 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
Requirements:
- Degree in Human Health or Sciences
- 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
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