Lead Computer System Validation and Compliance Specialist

5 days ago


Windsor, Windsor and Maidenhead, United Kingdom Lifelancer Full time
About the Role

We are seeking an experienced GxP Regulatory Expert to lead our Computer System Validation (CSV) audits in a hybrid setting. As a key member of our quality team, you will be responsible for managing and performing audits with a focus on CSV compliance.

In close collaboration with our Head of Global Quality Management, you will support the audit process by developing and maintaining an adequate audit plan, selecting and managing qualified service providers, and managing audits in line with our business model and procedures.

Key Responsibilities:
  • Develop and Implement Audit Plans: Create and maintain effective audit plans for global, regional, and local computerized systems and compliance processes.
  • Select and Manage Service Providers: Identify and manage qualified contract auditors to support our global quality initiatives.
  • Audit Management: Lead and coordinate audits, ensuring compliance with regulatory requirements and company procedures.
  • Corrective Actions: Follow up on the development, implementation, and completion of corrective actions with internal and external auditees.
About You

To succeed in this role, you will need:

  • Expert Knowledge: GxP regulations, CSV guidelines, and data integrity principles.
  • Leadership Experience: Proven experience as a lead auditor or in a similar leadership role.
  • Communication Skills: Excellent communication and interpersonal skills to collaborate with cross-functional teams.
What We Offer

As a valued member of our team, you can expect:

  • Competitive Salary: £80,000 - £110,000 per annum, depending on experience.
  • Flexible Working Arrangements: Hybrid work setup with opportunities for remote work.
  • Career Growth Opportunities: Ongoing training and professional development to enhance your skills.
  • Supportive Work Environment: Collaborative and inclusive work culture that values employee well-being.


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