Senior Validation Leader

3 weeks ago


Billingham County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

About FUJIFILM Diosynth Biotechnologies:

We are a trusted CDMO partner for life, committed to transforming people's lives and impacting where it matters most. As a global company united by Genki, we encourage you to discover what inspires you every day and follow your passion and power.

This exciting opportunity as a Senior Validation Leader will provide you with the chance to work closely with other leaders across sites and IT functional towers. You will be responsible for managing a global team of 3-8 direct reports, potentially situated across geographic sites.

The ideal candidate will have a strong background in computer system validation, documentation standards, and GAMP, with a proven track record of continuous improvement and effective communication. A competitive salary of $120,000 - $160,000 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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