Senior Specialist, IT Compliance – Validation

New York Blood Center

Senior Specialist ensuring FDA compliance for IT systems at New York Blood Center. Involved in system validation, audit readiness, and cross-functional collaboration with IT and Quality Assurance.

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

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Responsible for ensuring that FDA-regulated computerized systems are validated, controlled, and maintained in compliance with regulatory requirements.
Supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity.
Partners closely with IT, Quality Assurance, Regulatory Affairs, and system owners to maintain compliance across enterprise platforms.
Execute Computer System Validation (CSV) Activities and lead and document validation lifecycle deliverables.
Develop, execute, and maintain automated regression test suites to ensure system functionality remains stable.
Document automated test evidence and ensure results meet inspection-ready standards.
Prepare validation documentation and serve as IT compliance support during internal audits and FDA inspections.
Conduct Risk-Based Validation Assessments and apply GAMP 5 and risk-based methodologies.
Support compliance metrics tracking and management reporting activities.

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).
Understanding of IT change management, access controls, audit trails, and system lifecycle management in regulated environments.
Familiarity with SaaS and cloud-based system validation considerations.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account New York Blood Center Website LinkedIn All Job Openings 1001 - 5000 employees Founded 1964 ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals Healthcare Insurance
Biotechnology
Pharmaceuticals New York Blood Center is one of the largest independent, community-based blood centers in the United States, having proudly served the community since 1964. It provides high-quality blood and stem cell products, along with related medical and consultative services to hospitals and patients. NYBCe is also deeply involved in research focused on blood-related diseases and therapies, including the development of cell and gene therapies, aimed at improving treatment outcomes for patients. Senior Specialist, IT Compliance – Validation 🔥 1 hour ago 🏢🏡 Rye – Hybrid 💵 $120k - $130k / year ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Responsible for ensuring that FDA-regulated computerized systems are validated, controlled, and maintained in compliance with regulatory requirements.
Supports the full computer system validation (CSV) lifecycle and ensures IT systems remain in a state of control, audit readiness, and data integrity.
Partners closely with IT, Quality Assurance, Regulatory Affairs, and system owners to maintain compliance across enterprise platforms.
Execute Computer System Validation (CSV) Activities and lead and document validation lifecycle deliverables.
Develop, execute, and maintain automated regression test suites to ensure system functionality remains stable.
Document automated test evidence and ensure results meet inspection-ready standards.
Prepare validation documentation and serve as IT compliance support during internal audits and FDA inspections.
Conduct Risk-Based Validation Assessments and apply GAMP 5 and risk-based methodologies.
Support compliance metrics tracking and management reporting activities. 🎯 Requirements
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).
Understanding of IT change management, access controls, audit trails, and system lifecycle management in regulated environments.
Familiarity with SaaS and cloud-based system validation considerations. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

computer system validationIT compliancevalidation lifecycle documentationautomated regression testingrisk assessmentstechnical writingdata integrityGAMP 521 CFR Part 11GxP regulations

Soft Skills

collaborationcommunicationdocumentationaudit readinessattention to detailproblem-solvingorganizational skillsleadership