QA Validation Compliance Lead

Responsible for managing Validation Compliance activities for the Pirbright site, ensuring that all validation processes, documentation and systems meet GMP, GxP and corporate requirements. Fixed‑term contract until 31 December 2027.

Tasks & Responsibilities

• Validation Compliance Oversight
  • Manage Validation Compliance activities to ensure operational site objectives are met within agreed timelines.
  • Exchange knowledge and expertise with cross‑functional teams, ensuring the site is supported by an expert and flexible Validation Compliance function.
  • Plan, resource and manage external contractors’ scopes of work, ensuring effective oversight and communication.
  • Oversight and approval of validation activities and documentation applicable to the Pirbright site.
  • Serve as Compliance and Regulatory Subject Matter Expert for validation and qualification aspects of projects.
  • Approve internal procedures and policies related to validation.
  • Oversee compliance of validation processes and support the definition of validation strategies.
  • Maintain oversight and ownership of Site Validation Master Plans.
• Validation Documentation & Quality Support
  • Ensure validation documentation meets corporate procedures, policies and GMP regulations.
  • Work closely with the Validation Execution team and other site functions to ensure best practices in validation documentation and generation of protocols and reports.
  • Manage compliance‑related project activities, ensuring alignment with regulatory timelines and requirements.
  • Conduct periodic reviews of validation systems and ensure validated status is maintained.
  • Provide site visibility of validation performance through monthly KPI reporting and annual reviews.
• Audits & Regulatory Support
  • Support Quality Management System activities including audits, inspections, CAPAs, Change Controls and Risk Assessments.
  • Participate in vendor audits and support corporate Supplier & Service Provider Audits.
  • Ensure adherence to BI and regulatory requirements related to validation.
  • Provide SME support during external and internal inspections.
• Cross‑Functional Collaboration
  • Work with colleagues, contractors, suppliers, stakeholders and process owners to understand validation needs and requirements.
  • Join cross‑functional development teams for review and approval of modifications to equipment, processes and systems.
  • Share expertise to drive continuous improvement and aligned validation practices across the site.
• Industry & Compliance Monitoring
  • Investigate trends in validation and regulatory expectations, updating local systems accordingly.
  • Perform gap analyses to assess compliance risk and propose improvements.
  • Attend seminars and training events to remain up to date with industry expectations and regulatory changes.

Requirements

Education

• Degree qualified in a related science or engineering discipline, or formal qualification relating to validation or quality.

Skills & Experience

• Extensive experience in validation roles or other relevant experience.
• Previous experience in a pharmaceutical or GMP‑regulated environment desirable.
• Strong experience with validation and qualification, including Equipment, CSV, Facilities & Utilities, Process Validation and Cleaning Validation.
• Experience in aseptic production and biologics beneficial.
• Strong understanding of current GMPs, validation requirements and risk assessment principles.
• Proven ability to work autonomously and lead within a team environment.
• Strong written and verbal communication skills.
• Excellent organisational skills and attention to detail.
• Strong analytical and problem‑solving abilities.
• Ability to manage time and resources efficiently and adapt to changing priorities.
• Ability to influence and collaborate effectively with other departments.
• Proactive mindset with capability to identify issues and drive appropriate solutions.
• Strong computer literacy (MS Office, Teams, other GxP systems).

A Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to satisfactory DBS certificate.