Senior Specialist, IT Compliance & Validation
New York Blood Center Enterprises · Rye, New York, US
Responsibilities The Senior Specialist, IT Compliance & Validation is responsible for ensuring that FDA-regulated computerized systems, as well as other crit...
Job description
Responsibilities The Senior Specialist, IT Compliance & Validation is responsible for ensuring that FDA-regulated computerized systems, as well as other critical enterprise systems are validated, controlled, and maintained in compliance with applicable regulatory requirements, including 21 CFR Part 11, 21 CFR Part 210/211, and other relevant GxP standards. This role supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity. The position partners closely with IT, Quality Assurance, Regulatory Affairs, and system owners to maintain compliance across enterprise platforms. Candidates must be able to report into one of the following NYBCe locations: Rye, New York; Kansas City, Missouri; St. Paul, Minnesota; Providence, Rhode Island, and Newark, Delaware. Execute Computer System Validation (CSV) Activities - Lead and document validation lifecycle deliverables (URS, FRS/DS, Risk Assessments, Validation Plans, IQ/OQ/PQ, Validation Reports, Traceability Matrices, Automated Testing Artifacts) to ensure FDA-regulated systems remain in a validated state. Automated Testing Development & Execution: Ensure...