Senior Specialist, IT Compliance & Validation
1 day ago
Rye
Job Locations US-NY-Rye Job ID 2026-8410 Category Information Technology Minimum Rate USD $120,000.00/Yr. Maximum Rate USD $130,000.00/Yr. Work Location Type Physical 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. 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 • Develop, execute, and maintain automated regression test suites to ensure system functionality remains stable across patches, upgrades, and configuration changes., • Design and apply automated stress, load, and performance testing to verify system reliability, throughput, and behavior under expected and peak usage conditions., • 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., • Evaluate IT changes for regulatory impact and ensure appropriate validation activities are performed prior to implementation., • Evaluate the need for automated regression testing as part of change impact assessments for upgrades, patches, configuration changes, and infrastructure modifications., • Apply GAMP 5 and risk-based methodologies to determine validation scope and control requirements., • Assist in investigating compliance gaps, audit findings, and FDA observations; implement corrective and preventive actions as required., • Provide compliance guidance and training support to IT and business stakeholders., • Identify and implement process improvements to enhance validation efficiency and effectiveness., • Support compliance metrics tracking and management reporting activities., • Participate in periodic system reviews and revalidation efforts to maintain validated state., • Assist in vendor qualification and third-party compliance oversight activities., • Contribute to IT risk assessments and integration of cybersecurity considerations into validation processes., • Maintain validation documentation repositories and ensure proper document control practices., • 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., • 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., • Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds., • Strong technical writing and documentation skills within a regulated framework., • Ability to perform risk assessments and regulatory impact analyses., • Analytical and problem-solving skills related to compliance gaps and remediation activities., • Ability to review and interpret vendor validation documentation and SOC reports., • Effective cross-functional communication skills with IT, Quality, and Regulatory stakeholders., • Ability to interpret and apply FDA regulatory guidance to IT systems., • Ability to maintain systems in a validated state through structured lifecycle controls., • Ability to support audits and regulatory inspections with clear, defensible documentation., • Ability to identify compliance risks and recommend practical mitigation strategies., • Ability to work independently while collaborating in a regulated, cross-functional environment. 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. 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. Please see salary ranges for locations: Providence, RI, $110,000 - $120,000 St. Paul, MN $110,000 - $120,000 Lincoln, NE $105,000 - $115,000 Newark, DE $105,000 - $115,000 Kansas City, MO $105,000 - $115,000 Founded in 1964, New York Blood Center (NYBC) 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.