Sr. Engineer, Digital Systems Quality Assurance
12 months
Location: Bridgewater, NJ Hybrid
Pay range: $58-63/hr.
Position Summary
The Senior Associate, Digital Systems Quality Assurance (Contractor) is responsible for providing GxP quality oversight and hands-on validation support for a global portfolio of computerized systems and digital platforms. This role partners closely with IT, Digital Quality, and cross-functional business teams to ensure that enterprise GxP systems--including Quality Management Systems (QMS), clinical and laboratory systems, enterprise platforms, and emerging AI/ML-enabled applications--are validated, compliant, and operationally sound in accordance with 21 CFR Part 11, EU Annex 11, EMA Draft Annex 22, FDA Computer Software Assurance (CSA) principles, and ISPE GAMP 5 guidance.
This role will play a critical part in establishing and executing compliant validation practices for AI-enabled digital capabilities, ensuring that quality, patient safety, and data integrity are maintained in alignment with evolving regulatory expectations.
Responsibilities
• Lead or support end-to-end GxP computerized system validation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ/PQ protocols, Traceability Matrices (RTM), and Validation Summary Reports (VSRs), in alignment with FDA CSA principles and ISPE GAMP 5 guidance.
• Apply risk-based validation approaches to right-size efforts based on system complexity, intended use, product quality, and patient safety impact.
• Maintain validation lifecycle documentation for enterprise GxP systems (e.g., Veeva Vault Quality, Veeva Medical, Veeva RIM, ServiceNow, and TraceLink), clinical systems (e.g., EDC, IRT, eCOA, eTMF), and analytical/laboratory systems (e.g., LIMS, CMMS, EMS) in compliance with 21 CFR Part 11 and EU Annex 11.
• Evaluate change controls to determine revalidation scope, conduct periodic reviews of validated systems, and maintain validated status throughout the system lifecycle.
• Author, review, and approve GxP documentation, including SOPs, Work Instructions, and validation deliverables, ensuring compliance with ALCOA+ data integrity principles.
• Author or review intended-use documents with input sample space characterization; define risk-based acceptance criteria that meet or exceed the performance of the process being replaced, with process SME ownership.
• Implement test data independence controls, including access-controlled repositories, audit trails, and staff separation, to prevent hold-out test set exposure during model development.
• Evaluate whether changes to models, systems, or physical inputs require retesting and fully document decisions not to retest.
• Define and track drift metrics for input sample space adherence and model output quality, escalating deviations in accordance with EMA Draft Annex 22 and FDA CSA expectations.
• Design and maintain human-in-the-loop (HITL) oversight procedures for AI-assisted GMP decisions, including reviewer qualifications, review SOPs, per-output records, and monitoring of operator agreement and override rates.
• Support explainability assessments (e.g., SHAP values, LIME, and heat maps) during acceptance testing, where applicable.
• Conduct or support supplier qualification assessments for GxP system vendors, including review of audit reports, vendor questionnaires, Quality/Technical Agreements, and regulatory submission support documentation.
• For AI/ML vendor-supplied models, assess supplier test data independence practices, including access logs, repository controls, and staff separation, and review vendor-held training, validation, and testing documentation in accordance with regulated user obligations under Draft Annex 22 Section 2.2.
• Maintain the GxP computerized system portfolio in a constant state of inspection readiness and serve as a subject matter expert during FDA, EMA, and other regulatory agency inspections involving computerized system validation.
Required Skills & Qualifications
• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field required; advanced degree preferred.
• Minimum of 7 years of GxP computerized system validation experience in the FDA-regulated pharmaceutical or biotechnology industry, with a demonstrated track record of end-to-end lifecycle management across enterprise, clinical, and/or laboratory systems.
• In-depth knowledge of 21 CFR Part 11 and EU EudraLex Volume 4 Annex 11, with practical experience applying electronic records, electronic signatures, audit trails, and access control requirements to validated GxP systems.
• Strong working knowledge of ISPE GAMP 5 principles, including software categorization (Categories 1-5), risk-based lifecycle validation, and supplier assessment, combined with demonstrated understanding of FDA Computer Software Assurance (CSA) guidance.
• Hands-on experience validating enterprise GxP systems. Direct experience with one or more of the following is strongly preferred: Veeva Vault (QMS, RIM, MedComms), ServiceNow (GxP modules), Qlik, or Entra ID.
• Working knowledge of clinical systems (e.g., EDC, IRT, eTMF, CTMS) and/or QC laboratory systems (e.g., LIMS, CDS, ELN) validation principles, including experience with on-premise, SaaS, and cloud-hosted system qualification.
• Experience supporting GxP validation or quality oversight of AI/ML-enabled computerized systems, including familiarity with AI model classification (static vs. dynamic, deterministic vs. probabilistic) and criticality assessment based on direct impact to patient safety, product quality, or data integrity, in alignment with EMA Draft Annex 22.
• Working knowledge of AI model lifecycle controls, including intended-use documentation with input sample space characterization, test data independence requirements (access-controlled repositories, audit trails, and staff separation), and acceptance criteria that meet or exceed the performance of the process being replaced.
• Familiarity with human-in-the-loop (HITL) oversight design for AI-assisted GMP decisions and production monitoring concepts, including input sample space drift detection.
• Experience reviewing supplier-held AI training, validation, and test data independence documentation as part of vendor qualification activities.
• Demonstrated experience supporting regulatory inspections and audit readiness activities.
• Experience with quality systems processes, including Change Control, Deviation Management, CAPA, and Supplier Quality.