Senior Validation Leader
3 weeks ago
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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