Senior Specialist, IT Compliance – Validation

New York Blood Center

Senior Specialist, IT Compliance & Validation overseeing FDA-regulated systems and ensuring compliance with IT validation lifecycle requirements. Partnering with cross-functional teams across the organization.

Posted 5/14/2026full-timeNew York City • Minnesota, Montana, New York, Rhode Island • 🇺🇸 United StatesSenior💰 $120,000 - $130,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for ensuring that FDA-regulated computerized systems are validated, controlled, and maintained in compliance with applicable regulatory requirements.
Support the full computer system validation (CSV) lifecycle and ensure IT systems remain in a state of control, audit readiness, and data integrity.
Partner closely with IT, Quality Assurance, Regulatory Affairs, and system owners to maintain compliance across enterprise platforms.
Lead and document validation lifecycle deliverables.
Develop, execute, and maintain automated regression test suites.

Requirements

What you’ll need

Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or a related discipline.
Minimum of 6-8 years of experience in computer system validation (CSV), IT compliance, or IT quality within an FDA-regulated environment.
Demonstrated working knowledge of 21 CFR Part 11 and applicable GxP regulations.
Experience executing validation lifecycle documentation (e.g., URS, risk assessments, IQ/OQ/PQ, traceability matrices).
Experience supporting internal audits and/or FDA regulatory inspections.
Strong technical writing and documentation skills in a regulated environment.
Working knowledge of FDA regulations applicable to computerized systems, including 21 CFR Part 11 and relevant GxP requirements.
Knowledge of computer system validation (CSV) lifecycle methodologies (URS, risk assessments, IQ/OQ/PQ, traceability).
Understanding of FDA data integrity principles (ALCOA+).
Knowledge of risk-based validation approaches (e.g., GAMP 5).

Benefits

Comp & perks

Health insurance
Professional development opportunities
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

computer system validationIT complianceIT qualityautomated regression testingvalidation lifecycle documentationrisk assessmentsIQ/OQ/PQtraceability matricesrisk-based validationGAMP 5

Soft Skills

technical writingdocumentation skillscollaborationcommunication