IT Technical Regulatory Compliance Principal
Rochester Regional Health(1 month ago)
About this role
The IT Technical Regulatory Compliance Principal oversees IT computer systems validation and regulatory compliance programs supporting laboratory services and clinical trials research. The role ensures IT infrastructure, cloud-hosted and SaaS applications, and laboratory systems meet applicable regulatory frameworks (FDA, MHRA, EMEA, GLP, GCP) and align with company quality policies. The position operates in the United States with hybrid work expectations and serves as a key liaison between IT, quality, and business stakeholders.
Required Skills
- Computer Validation
- Risk Assessment
- IQ OQ PQ
- SDLC
- Change Management
- Documentation
- Regulatory Audits
- CAPA Management
- GxP Compliance
- Cloud Validation
+5 more
Qualifications
- BS in Computer Science
- ISPE GAMP 5
About Rochester Regional Health
rochesterregional.orgRochester Regional Health is an integrated health services organization serving the people of Western New York, the Finger Lakes, and beyond.
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