Quality Systems Engineer

The Senior Engineer, Digital Systems Quality Assurance provides quality oversight for GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, ICH, and other applicable regulatory requirements. This role partners with IT, business, validation, and vendor teams to support system implementation, validation, change management, and ongoing compliance while maintaining a validated state and protecting patient safety, product quality, and data integrity. Responsibilities Provide quality oversight for GxP computerized systems throughout implementation, validation, operation, maintenance, and retirement. Serve as the primary QA contact for enterprise GxP systems, supporting validation, change control, lifecycle management, and compliance activities. Review and approve computer system validation (CSV) documentation, including requirements, validation plans, protocols, test scripts, and summary reports. Ensure compliance with 21 CFR Part 11, Annex 11, data integrity, electronic records, electronic signatures, and audit trail requirements. Perform risk assessments and apply risk-based validation strategies using FDA Computer Software Assurance (CSA) and ISPE GAMP 5 principles. Review and approve change controls, deviations, CAPAs, periodic reviews, and quality documentation. Support supplier qualification, audits, regulatory inspections, and inspection readiness activities. Develop and maintain quality procedures, provide compliance guidance and training, and monitor evolving regulatory requirements. Support quality oversight for cloud-based, SaaS, and AI/ML-enabled GxP computerized systems. Qualifications Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field preferred. Minimum of 7 years of Quality Assurance and/or Computer System Validation experience within the pharmaceutical or biotechnology industry. Strong knowledge of GxP computerized system lifecycle management, 21 CFR Part 11, Annex 11, FDA CSA, ISPE GAMP 5, and data integrity principles. Experience supporting enterprise GxP applications, validation activities, supplier qualification, regulatory inspections, and audit readiness. Familiarity with quality systems processes, including Change Control, Deviations, CAPA, Supplier Quality, and risk management. Experience with cloud-based and SaaS platforms; knowledge of AI/ML validation frameworks is preferred. Professional quality certifications (e.g., ASQ CSQE, CQE, CQA) are a plus. #J-18808-Ljbffr