Compliance and Validation Director
5 days ago
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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