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Brighton, Brighton and Hove, United Kingdom DNA Life Sciences Full time

The Validation Director at DNA Life Sciences leads all validation activities, ensuring compliance with EU GMP guidelines and other relevant regulations. They are responsible for developing and implementing the Site Validation Master Plan (SVMP) and validation policies.

Key responsibilities include:

  • Leading the validation team and tracking departmental KPIs.
  • Ensuring the team has the capacity and capability to deliver the SVMP schedule.
  • Supporting validation and qualification activities for new facilities and ongoing operations.
  • Developing the team's skills to handle inspections confidently.
  • Driving continuous improvement and best practices within the function.
  • Managing the Validation Master Plan to ensure all systems comply with regulations.
  • Implementing validation standards and operating procedures.
  • Providing technical expertise and framework for validation documentation.
  • Planning and executing ongoing process verification and equipment re-qualification.
  • Managing change controls, non-conformances, CAPAs, and effectiveness checks.
  • Representing the site during inspections and audits.
  • Advising on regulatory queries and submissions.
  • Ensuring protocol deviations are addressed promptly.
  • Applying Good Manufacturing Practice principles and promoting company values.

**Requirements:**

  • Degree in science or engineering.
  • Experience in biotechnology/pharmaceutical industries, specifically in GMP validation.
  • Experience in aseptic/sterile GMP manufacturing.
  • Strong leadership, communication, problem-solving skills, and a proactive approach.
  • Knowledge of relevant industry standards and best practices (Annex 11, Annex 15, GAMP 5, ICH Q8/9/10).