• Serve as the system administrator and execution owner for all electronic GxP systems and GxP supporting applications used to create, manage, store, or report regulated quality data • Maintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownership • Ensure all applicable systems are appropriately classified for GxP impact, validated and maintained in a validated state, traceable to intended use and regulatory requirements, and defensible during audits and inspections • Serve as the primary or backup system administrator for multiple electronic systems platforms, for example: platforms and systems supporting document control, training, change control, deviations, investigations, CAPA, audit, customer complaint workflows, electronic batch records, external submissions, and device history file(s) • Configure, maintain, and execute system workflows and forms, metadata and taxonomy structures, user roles, permissions, and security models • Controlled system changes in accordance with validation requirements • Provide quality system execution oversight for GxP-supporting applications that interface with or support GxP activities (e.g. reporting tools, repositories, workflow platforms, and validated interfaces) • Partner with Information Technology and systems owners to ensure appropriate approach and documentation, controlled access and data protection(s), and change management aligned with GxP risk profile • Execute and support system validation activities across the system lifecycle, including validation planning and impact assessments, IQ/OQ/PQ documentation and test execution, and validated evidence maintenance and archival • Ensure all system changes, upgrades, and enhancements follow approved change control and validation procedures • Maintain inspection-ready validation documentation at all times • Develop, maintain, and execute system-level reports while ensuring system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+) • Serve as a system subject matter expert (SME), including back-room inspection support and direct system demonstrations as required • Provide day-to-day technical support for electronic GxP systems, including issue triage, troubleshooting, and resolution while evaluating new system features and tools to provide recommendations based on compliance and operational impact • Participate in industry forums, user groups, and training related to electronic GxP systems and validation best practices