7+ years of experience in computerized system validation within FDA-regulated environments.
Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field; advanced degree preferred.
Proven track record managing end-to-end GxP validation activities.
Strong knowledge of 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and FDA CSA.
Experience with enterprise GxP platforms like Veeva Vault and ServiceNow.
Familiarity with validation for clinical and laboratory systems.
Understanding of AI/ML validation requirements and emerging regulatory expectations.
Responsibilities
Lead computerized system validation activities for GxP applications and digital quality solutions.
Develop and maintain comprehensive validation documentation including URS and validation summary reports.
Apply risk-based validation strategies in compliance with regulatory standards.
Provide quality oversight for enterprise platforms and evaluate system changes.
Support qualification of SaaS and cloud-hosted GxP applications.
Establish validation approaches for AI/ML-enabled systems and assess model testing practices.
Maintain inspection-ready documentation and support regulatory inspections.
Benefits
Long-term contract assignment of approximately 11 months.
Full-time schedule of 40 hours per week.
Opportunity to work with cutting-edge AI/ML technologies in GxP environments.
Exposure to evolving regulatory expectations in the pharmaceutical industry.
Full Job Description
Job Description What's In Store For You
Location: Bridgewater, NJ.
Schedule: Full-time, 40 hours per week.
Engagement: W2 only (no C2C/1099).
Contract: Long-term assignment, approximately 11 months.
Work with enterprise GxP platforms supporting pharmaceutical quality, clinical, laboratory, and regulatory operations.
Contribute to the development of risk-based validation practices for AI/ML-enabled systems.
Collaborate with multidisciplinary teams on computerized system lifecycle management, regulatory compliance, and digital quality initiatives.
Gain exposure to evolving regulatory expectations surrounding AI-assisted GxP processes.
How You Will Make An Impact
Lead and execute computerized system validation activities across enterprise GxP applications, clinical technology platforms, laboratory systems, and digital quality solutions.
Develop and maintain validation documentation, including Validation Plans, User Requirements Specifications (URS), functional specifications, IQ/OQ/PQ protocols, Requirements Traceability Matrices (RTM), and Validation Summary Reports (VSR).
Apply risk-based validation strategies aligned with FDA Computer Software Assurance (CSA), ISPE GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements.
Provide quality oversight for enterprise platforms such as Veeva Vault, ServiceNow, and other regulated business applications.
Evaluate system changes, software upgrades, and configuration modifications to determine appropriate validation and revalidation activities.
Support qualification of SaaS, cloud-hosted, and on-premises GxP applications while ensuring appropriate electronic record controls, audit trails, and access management.
Establish and evaluate validation approaches for AI/ML-enabled GxP systems, including intended-use assessments, model risk classification, acceptance criteria, and lifecycle controls.
Assess AI model testing practices, including test data independence, input data characterization, and safeguards against inappropriate exposure of validation datasets.
Support monitoring strategies for AI-enabled applications, including model drift detection, performance monitoring, and evaluation of changes affecting validated system performance.
Review supplier qualification documentation, technical agreements, validation evidence, and third-party quality controls for computerized systems and AI-enabled solutions.
Support deviation investigations, CAPA activities, change control, and periodic system reviews to maintain compliance throughout the computerized system lifecycle.
Partner with internal stakeholders to ensure validation documentation follows ALCOA+ data integrity principles.
Maintain inspection-ready documentation and provide computerized system validation expertise during regulatory inspections and quality audits.
Requirements Do You Bring Proven Success in GxP Computer System Validation and Digital Quality Assurance?
7+ years of hands-on computerized system validation experience within FDA-regulated pharmaceutical or biotechnology environments.
Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline; advanced degree preferred.
Demonstrated experience managing end-to-end GxP computerized system validation activities, from initial requirements through testing, approval, and ongoing lifecycle maintenance.
Strong practical knowledge of 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and FDA Computer Software Assurance (CSA).
Experience developing, reviewing, and approving validation documentation, including URS, IQ/OQ/PQ, RTM, risk assessments, and validation summary reports.
Hands-on experience supporting enterprise GxP platforms, preferably Veeva Vault Quality, Veeva RIM, Veeva Medical, ServiceNow, Qlik, or similar regulated applications.
Understanding of computerized system controls involving electronic records, electronic signatures, audit trails, user access, and data integrity.
Familiarity with validation requirements for clinical systems such as EDC, IRT, eTMF, and CTMS, or laboratory systems such as LIMS, CDS, and ELN.
Experience supporting computerized system qualification across SaaS, cloud-based, and traditional enterprise environments.
Experience providing quality oversight or validation support for AI/ML-enabled computerized systems, including model criticality, intended use, and validation risk assessments.
Knowledge of AI model lifecycle controls, independent test datasets, acceptance criteria, model monitoring, and human-in-the-loop oversight.
Familiarity with emerging regulatory expectations for AI applications in GxP environments, including EMA Draft Annex 22.
