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.
• Document automated test evidence and ensure results meet inspection‑ready standards.

Ensure Compliance with 21 CFR Requirements

• Assess and maintain compliance with 21 CFR Part 11 and other applicable FDA regulations governing electronic records, electronic signatures, and GxP computerized systems.

Support Change Control & System Lifecycle Management

• 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.
• Maintain automated regression test libraries to ensure adequate coverage of high‑risk GxP functions throughout the system lifecycle.

Maintain Inspection Readiness

• Prepare validation documentation and serve as IT compliance support during internal audits and FDA inspections.

Assess and Monitor Data Integrity Controls

• Verify systems meet FDA data integrity expectations (ALCOA+), including audit trails, access controls, and record retention.

Perform Risk-Based Validation Assessments

• Apply GAMP 5 and risk-based methodologies to determine validation scope and control requirements.
• Define and maintain automation strategies for high‑risk, high‑frequency, or high‑complexity system functions.

Review Vendor and SaaS Compliance Documentation

• Evaluate supplier validation packages, SOC reports, and system documentation to ensure regulatory alignment.

Collaborate Cross-Functionally

• Partner with IT, Quality & Regulatory Affairs, and system owners to ensure compliance requirements are integrated into system design and operation.

Contribute to IT Compliance Governance

• Support development and updates of IT validation SOPs, policies, and procedures to align with FDA guidance.

Support Remediation & CAPA Activities

• 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.
• Serve as IT compliance representative on system implementation and upgrade projects.

Education:

• Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or a related discipline.

Experience:

• 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.

Knowledge:

• 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.

Skills:

• 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.
• Organizational skills with the ability to manage multiple validation activities concurrently.

Abilities:

• 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:

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