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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Engineer, Digital Systems Quality Assurance - **Company:** Planet Pharma - **Location:** Raritan, NJ, United States - **Experience:** Expert - **Salary:** $104,000.0 - $124,800.0 - **Contract:** Temporary contract - **Skills:** Artificial Intelligence, Software Applications, Audit Trail, Clinical Trial Management Systems, Software as a Service, Data Integrity, Digital Technology, Enterprise Document Management System, Electronic Signatures, Laboratory Information Management Systems, System Testing, Test Scripts, Computerised Systems, Information Technology, Qlikview, Veeva, VeevaVault, GXP, Servicenow - **Published:** August 4, 2026 - **Apply:** https://www.disabledperson.com/jobs/73990043-sr-engineer-digital-systems-quality-assurance ## About the Role * GxP Computer System Validation * 21 CFR PART 11 COMPLIANCE * EUDRALEX VOLUME 4 ANNEX 11 COMPLIANCE, * In-depth knowledge of 21 CFR Part 11 and Eudralex Volume 4 Annex 11, with practical experience applying these to electronic records, electronic signatures, audit trails, and access controls. * Strong working knowledge of ISPE GAMP 5 principles, including software categorization (Categories 1-5), supplier assessment, and risk-based lifecycle validation. * Demonstrated understanding of FDA Computer Software Assurance (CSA) guidance and ability to define right-sized validation strategies aligned to patient safety risk, product quality, and data integrity. * Hands-on experience with Enterprise GxP systems; direct experience with one or more of the following strongly preferred: Veeva Vault (QMS, RIM, MedComms, MedInquiry), ServiceNow, 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, Empower) validation principles. * Experience with on-premise, SaaS, and cloud-hosted systems, including supplier qualification and audit activities. * Solid understanding of data integrity principles and ALCOA+ requirements for electronic records and computerized systems. * Awareness of emerging AI/ML validation frameworks (e.g., ISPE GAMP AI Guide) and their application to GxP-regulated AI systems preferred. * Quality Professional Certifications (e.g., ASQ CSQE, CQE, CQA) preferred. Education * Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field preferred. * Minimum 7 years of experience in Quality Assurance and/or Validation within the FDA-regulated pharmaceutical or biotechnology industry, with a demonstrated track record of supporting GxP computerized system lifecycle management. * Demonstrated experience supporting regulatory inspections and audit readiness activities. * Experience with quality systems processes including Change Control, Deviation management, CAPA, and Supplier Quality. ## Description * Provides quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements in support of patient safety and product quality. * Serves as a primary QA partner for Enterprise-level GxP systems - including Veeva Quality (Vault QMS), Veeva RIM, Veeva MedComms, Veeva MedInquiry, ServiceNow, Qlik, and Entra ID - supporting implementation, validation, and ongoing lifecycle management. * Maintains foundational understanding of GxP Computer systems validation principles to support cross-functional collaboration and holistic quality oversight. * Partners with IT, business, CSV and vendor teams to apply risk-based approaches, maintain validated state, and drive continuous compliance. * Applies proficiency in key Quality Systems processes including Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit, and Quality Complaints. * Contributes to the organization's digital quality strategy as a subject matter expert in computerized system validation and lifecycle management. * Driven by a genuine commitment to patient safety and a passion for ensuring that the digital systems supporting drug development and commercialization are compliant, reliable, and trustworthy. Responsibilities: * Provide QA oversight for GxP computerized systems across their full lifecycle (implementation, operation, maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations. * Serve as the primary QA point of contact for Enterprise GxP systems (Veeva Vault QMS/RIM/MedComms/MedInquiry, ServiceNow, Qlik, Entra ID), supporting validation, change control, and lifecycle management activities. * Review and approve CSV deliverables including User Requirement Specifications (URS), Functional Specifications (FS), validation plans, protocols, test scripts, and summary reports. * Ensure practical compliance with 21 CFR Part 11 and Eudralex Volume 4 Annex 11 as applied to electronic records, electronic signatures, audit trails, and system access controls. * Independently assess GxP risk of systems and system enhancements - evaluating patient safety impact, product quality risk, and data integrity implications - and define a right-sized validation strategy applying FDA CSA and ISPE GAMP 5 principles. * Perform QA review and approval of change control records, deviations, CAPAs, and periodic reviews for GxP computerized systems. * Support development, review, and approval of SOPs, work instructions, and procedural documents related to computerized system lifecycle management. * Provide QA support during supplier qualification, audits, and system implementation projects, including SaaS and cloud-based solutions. * Participate in inspection readiness activities and provide direct support during regulatory inspections and audits. * Monitor industry trends and regulatory updates (FDA, EMA, ICH, ISPE/GAMP) to ensure QA practices remain current. * Provide training and guidance to business and IT stakeholders on quality and compliance expectations for GxP computerized systems. * Support validation and quality oversight of AI/ML-enabled computerized systems, applying risk-based CSA principles in alignment with ISPE GAMP AI guidance. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers)