Gene Therapy Validation Lead

4 days ago

London, Greater London, United Kingdom ZipRecruiter Full time
Salary: $140,000 - $170,000 per year.

About the Role:
We're seeking an ambitious and driven QC Validation Manager to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products in a highly regulated environment. This is a fantastic opportunity to work with a cutting-edge company developing innovative gene therapies addressing serious unmet medical needs.

Key Responsibilities:
  • 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.

Requirements:
  • 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.
  • Ability to travel between our UK and Ireland sites as required.

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