Senior Digital Systems Quality Assurance Engineer – GxP Computer System Validation & AI/ML Compliance

Be Part Of A High-Performing Team

Join an innovative biotechnology organization dedicated to advancing treatments for patients with serious and underserved medical conditions. With a strong commitment to scientific innovation, patient safety, and regulatory excellence, the organization continues to strengthen its digital infrastructure and quality systems to support the development and delivery of life-changing therapies.

This opportunity is part of a specialized Digital Systems Quality Assurance team responsible for maintaining compliance, reliability, and data integrity across GxP computerized systems. Working closely with IT, system owners, Quality Assurance, and cross-functional business stakeholders, the team provides independent quality oversight throughout the computerized system lifecycle.

As the organization continues to expand its digital capabilities, including emerging AI/ML-enabled applications, this role offers an opportunity to contribute to modern validation practices, strengthen regulatory compliance, and support the responsible adoption of new technologies within a highly regulated environment.

What's In Store For You

• Hybrid opportunity in Bridgewater, NJ, typically requiring 1–2 days onsite per week.
• Flexible onsite scheduling based on business needs, with additional onsite presence during inspections, User Acceptance Testing (UAT), or critical project activities.
• Long-term contract opportunity supporting a leading biotechnology organization.
• Engagement: W2 only (no C2C/1099).
• Opportunity to support enterprise, clinical, and other GxP computerized systems throughout their operational lifecycle.
• Exposure to emerging AI/ML technologies and evolving regulatory expectations for digital systems.
• Collaboration with experienced professionals across Digital Quality, IT, Quality Assurance, and business operations.
• Opportunity to contribute to risk-based validation strategies and continuous improvement of computerized system quality processes.

How You Will Make An Impact

• Provide independent Quality Assurance oversight throughout the computerized system lifecycle, including implementation, validation, operational maintenance, change management, and system retirement.
• Review and approve computerized system validation documentation, including Validation Plans, User Requirements Specifications (URS), risk assessments, IQ/OQ/PQ protocols, User Acceptance Testing (UAT), Requirements Traceability Matrices (RTM), and Validation Summary Reports (VSR).
• Partner with system owners, IT teams, and business stakeholders to provide guidance on validation strategies, regulatory requirements, and appropriate quality controls.
• Evaluate computerized system changes, conduct validation impact assessments, and ensure necessary testing, documentation, and approvals are completed before changes are deployed into production.
• Support ongoing compliance activities, including periodic system reviews, user access assessments, audit trail reviews, and maintenance of validated systems.
• Provide quality oversight for data migration activities, including migration planning, verification, and documentation, as well as computerized system decommissioning.
• Review deviations, root cause investigations, and Corrective and Preventive Actions (CAPA), providing guidance to system owners on appropriate investigation and remediation practices.
• Support supplier qualification activities through vendor assessments, questionnaires, documentation reviews, desktop audits, and remote supplier audits.
• Apply risk-based validation methodologies aligned with 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and FDA Computer Software Assurance (CSA) principles.
• Evaluate compliance and validation considerations for AI/ML-enabled GxP applications, including intended use, model risk, patient safety, product quality, and data integrity.
• Support the development of appropriate quality controls for AI-assisted processes, including human oversight, model performance expectations, and lifecycle monitoring, where applicable.
• Collaborate with cross-functional teams to resolve computerized system compliance challenges and maintain inspection-ready documentation.
• Provide guidance and hands-on support for validation and quality documentation when additional project resources are required.

Requirements

Do You Bring Proven Success in GxP Computer System Validation and Digital Quality Assurance?

• Minimum 5 years of hands-on GxP computerized system validation experience, preferably within FDA-regulated pharmaceutical or biotechnology environments; 7+ years strongly preferred.
• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline; advanced degree preferred.
• Demonstrated experience serving as a CSV validation lead or in a comparable capacity, with a strong understanding of the end-to-end computerized system lifecycle.
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and FDA Computer Software Assurance (CSA), including practical application of risk-based validation principles.
• Experience developing, reviewing, or approving computerized system validation documentation, including URS, validation plans, risk assessments, IQ/OQ/PQ, UAT, RTM, and validation summary reports.
• Experience providing independent Quality Assurance oversight for computerized system implementation, validation, change management, and operational compliance.
• Strong understanding of electronic records, electronic signatures, audit trails, access controls, and data integrity requirements in regulated GxP environments.
• Experience validating enterprise GxP systems or clinical computerized systems, with the ability to apply validation principles across different technology platforms.
• Familiarity with enterprise applications such as Veeva Vault Quality, Veeva RIM, Veeva Medical, ServiceNow, or comparable regulated systems is preferred.
• Knowledge of computerized system change control, impact assessments, periodic reviews, deviations, CAPA, and maintaining systems in a validated state.
• Familiarity with supplier qualification processes, including vendor assessments, supplier questionnaires, and quality documentation reviews.
• Foundational understanding of artificial intelligence and machine learning technologies, including their potential impact on GxP compliance, product quality, patient safety, and data integrity.
• Awareness of emerging regulatory expectations for AI/ML-enabled GxP applications, including EMA Draft Annex 22 and relevant FDA guidance.
• Direct experience validating AI/ML-enabled GxP systems is highly desirable but not required.
• Experience supporting regulatory inspections, audit readiness activities, and computerized system quality assessments is preferred.
• Strong analytical thinking, technical documentation, problem-solving, and regulatory decision-making capabilities.
• Excellent communication and stakeholder collaboration skills, with the ability to provide guidance to technical and nontechnical teams.
• Proactive, adaptable, and comfortable learning new systems, handling evolving priorities, and supporting additional quality or validation responsibilities as needed.