Sr. Compliance Specialist (Artificial Intelligence)
Thermo Fisher Scientific · Sofia, Bulgaria
IT & SoftwareFull timeCompany career page
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Role summary
Senior Compliance Specialist role focused on AI governance and validation within a GxP-regulated environment at Thermo Fisher Scientific. The position requires establishing compliance frameworks, standards, and controls for responsible AI adoption across the organization's systems and lifecycle.
What they're looking for
- Advanced degree plus 6 years relevant experience, or bachelor's degree plus 8 years in compliance, quality, or IT
- Expertise in AI-enabled systems governance, validation, and management in GxP environments
- Strong knowledge of regulatory standards including FDA 21 CFR Part 11, GxP, ICH GCP, EU AI Act, NIST framework
- Demonstrated experience with quality management systems, ISO standards, and compliance software
- Proficiency developing and implementing standard operating procedures (SOPs)
- Project management and risk assessment capabilities with strong stakeholder collaboration skills
- Advanced analytical and problem-solving abilities with excellent written and verbal communication
What you'll be doing
- Develop and implement AI-focused compliance programs addressing governance, validation, and risk management requirements
- Integrate AI-specific requirements into standard operating procedures and establish enterprise controls
- Develop and execute AI validation test strategies while mentoring team members on governance practices
- Represent IT organization on enterprise AI governance committees and support regulatory inspections and audits
- Provide general validation services for GxP applications including planning, risk assessments, and lifecycle compliance activities
Privacy & handoff
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