Senior Specialist, IT Compliance & Validation

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    "title": "Senior Specialist, IT Compliance & Validation",
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    "datePosted": "2026-05-13T04:00:00.000Z",
    "description": "<h2>Responsibilities</h2>\n<p>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.</p>\n<p> </p>\n<p>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.</p> \n<strong>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, Lincoln, Nebraska; and Newark, Delaware.</strong>\n<p> </p>\n<p><strong>Execute Computer System Validation (CSV) Activities</strong></p>\n<ul>\n <li>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.</li>\n</ul>\n<p><strong>Automated Testing Development & Execution</strong></p>\n<ul>\n <li>Develop, execute, and maintain automated regression test suites to ensure system functionality remains stable across patches, upgrades, and configuration changes.</li>\n <li>Design and apply automated stress, load, and performance testing to verify system reliability, throughput, and behavior under expected and peak usage conditions.</li>\n <li>Ensure automated test scripts are traceable to validation requirements, meet GxP expectations, and comply with 21 CFR Part 11 requirements for electronic records and audit trails.</li>\n <li>Document automated test evidence and ensure results meet inspection‑ready standards.</li>\n</ul>\n<p><strong>Ensure Compliance with 21 CFR Requirements</strong></p>\n<ul>\n <li>Assess and maintain compliance with 21 CFR Part 11 and other applicable FDA regulations governing electronic records, electronic signatures, and GxP computerized systems.</li>\n</ul>\n<p><strong>Support Change Control & System Lifecycle Management</strong></p>\n<ul>\n <li>Evaluate IT changes for regulatory impact and ensure appropriate validation activities are performed prior to implementation.</li>\n <li>Evaluate the need for automated regression testing as part of change impact assessments for upgrades, patches, configuration changes, and infrastructure modifications.</li>\n <li>Maintain automated regression test libraries to ensure adequate coverage of high‑risk GxP functions throughout the system lifecycle.</li>\n</ul>\n<p><strong>Maintain Inspection Readiness</strong></p>\n<ul>\n <li>Prepare validation documentation and serve as IT compliance support during internal audits and FDA inspections.</li>\n</ul>\n<p><strong>Assess and Monitor Data Integrity Controls</strong></p>\n<ul>\n <li>Verify systems meet FDA data integrity expectations (ALCOA+), including audit trails, access controls, and record retention.</li>\n</ul>\n<p><strong>Perform Risk-Based Validation Assessments</strong></p>\n<ul>\n <li>Apply GAMP 5 and risk-based methodologies to determine validation scope and control requirements.</li>\n <li>Define and maintain automation strategies for high‑risk, high‑frequency, or high‑complexity system functions.</li>\n</ul>\n<p><strong>Review Vendor and SaaS Compliance Documentation</strong></p>\n<ul>\n <li>Evaluate supplier validation packages, SOC reports, and system documentation to ensure regulatory alignment.</li>\n</ul>\n<p><strong>Collaborate Cross-Functionally</strong></p>\n<ul>\n <li>Partner with IT, Quality & Regulatory Affairs, and system owners to ensure compliance requirements are integrated into system design and operation.</li>\n</ul>\n<p><strong>Contribute to IT Compliance Governance</strong></p>\n<ul>\n <li>Support development and updates of IT validation SOPs, policies, and procedures to align with FDA guidance.</li>\n</ul>\n<p><strong>Support Remediation & CAPA Activities</strong></p>\n<ul>\n <li>Assist in investigating compliance gaps, audit findings, and FDA observations; implement corrective and preventive actions as required.</li>\n <li>Provide compliance guidance and training support to IT and business stakeholders.</li>\n <li>Identify and implement process improvements to enhance validation efficiency and effectiveness.</li>\n <li>Support compliance metrics tracking and management reporting activities.</li>\n <li>Participate in periodic system reviews and revalidation efforts to maintain validated state.</li>\n <li>Assist in vendor qualification and third-party compliance oversight activities.</li>\n <li>Contribute to IT risk assessments and integration of cybersecurity considerations into validation processes.</li>\n <li>Maintain validation documentation repositories and ensure proper document control practices.</li>\n <li>Serve as IT compliance representative on system implementation and upgrade projects.</li>\n</ul>\n<h2>Qualifications</h2>\n<p><strong><u>Education:</u></strong></p>\n<ul>\n <li>Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or a related discipline.</li>\n</ul>\n<p><strong><u>Experience: </u></strong></p>\n<ul>\n <li>Minimum of 6-8 years of experience in computer system validation (CSV), IT compliance, or IT quality within an FDA-regulated environment.</li>\n <li>Demonstrated working knowledge of 21 CFR Part 11 and applicable GxP regulations.</li>\n <li>Experience executing validation lifecycle documentation (e.g., URS, risk assessments, IQ/OQ/PQ, traceability matrices).</li>\n <li>Experience supporting internal audits and/or FDA regulatory inspections.</li>\n <li>Strong technical writing and documentation skills in a regulated environment.</li>\n</ul>\n<p><strong><u>Knowledge:</u></strong></p>\n<ul>\n <li>Working knowledge of FDA regulations applicable to computerized systems, including 21 CFR Part 11 and relevant GxP requirements.</li>\n <li>Knowledge of computer system validation (CSV) lifecycle methodologies (URS, risk assessments, IQ/OQ/PQ, traceability).</li>\n <li>Understanding of FDA data integrity principles (ALCOA+).</li>\n <li>Knowledge of risk-based validation approaches (e.g., GAMP 5).</li>\n <li>Understanding of IT change management, access controls, audit trails, and system lifecycle management in regulated environments.</li>\n <li>Familiarity with SaaS and cloud-based system validation considerations.</li>\n</ul>\n<p><strong><u>Skills:</u></strong></p>\n<ul>\n <li>Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.</li>\n <li>Strong technical writing and documentation skills within a regulated framework.</li>\n <li>Ability to perform risk assessments and regulatory impact analyses.</li>\n <li>Analytical and problem-solving skills related to compliance gaps and remediation activities.</li>\n <li>Ability to review and interpret vendor validation documentation and SOC reports.</li>\n <li>Effective cross-functional communication skills with IT, Quality, and Regulatory stakeholders.</li>\n <li>Organizational skills with the ability to manage multiple validation activities concurrently.</li>\n</ul>\n<p><strong><u>Abilities:</u></strong></p>\n<ul>\n <li>Ability to interpret and apply FDA regulatory guidance to IT systems.</li>\n <li>Ability to maintain systems in a validated state through structured lifecycle controls.</li>\n <li>Ability to support audits and regulatory inspections with clear, defensible documentation.</li>\n <li>Ability to identify compliance risks and recommend practical mitigation strategies.</li>\n <li>Ability to work independently while collaborating in a regulated, cross-functional environment.</li>\n</ul>\n<p> </p>\n<p>Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.</p>\n<p> </p>\n<p>For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $120,000.00p/yr. to $130,000.00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.</p>\n<p> </p>\n<p><strong>Please see salary ranges for locations:</strong></p>\n<p>Providence, RI,</p>\n<p>$110,000 - $120,000</p>\n<p>St. Paul, MN </p>\n<p>$110,000 - $120,000</p>\n<p>Lincoln, NE</p>\n<p>$105,000 - $115,000</p>Newark, DE\n<p>$105,000 - $115,000</p>Kansas City, MO\n<p>$105,000 - $115,000</p>\n<p> </p>\n<h2>Overview</h2>\n<p>Founded in 1964, <strong>New York Blood Center (NYBC)</strong> has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.</p>",
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