Compliance and Validation Director

5 days ago


Billingham County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

About the Opportunity:

FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Compliance and Validation Director to lead our IT compliance and validation team. The successful candidate will have extensive experience in computer system validation, documentation standards, and GAMP, with a proven track record of continuous improvement and effective communication.

This role offers a competitive salary of $150,000 - $200,000 per year, depending on experience, plus excellent benefits and opportunities for professional growth and development.

Responsibilities:

  • Develop global validation teams and processes
  • Support organization-wide compliance and regulatory requirements
  • Mentor internal resources
  • Continuously improve CSV delivery methodologies and internal processes
  • Develop vendor assurance practices
  • Verify external CSV resource requirements and deliverables
  • Cordinate IT audit responses

Requirements:

  • Bachelor's degree in engineering, computer science or similar
  • 10+ years industry relevant experience in computer system validation
  • Strong knowledge of documentation standards, particularly ISO and cGMP
  • Proven understanding of GAMP
  • High level of understanding within production and IT projects
  • Proven team management experience
  • Excellent communication and interpersonal skills


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