Senior Specialist, IT Compliance & Validation

Responsibilities

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.

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, and Newark, Delaware.

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…