Systems Administrator, Electronic GxP Systems

Kaleo Software

Systems Administrator ensuring validated electronic GxP systems at Kaléo. Managing quality oversight in drug-delivery device technology remotely with occasional travel.

Posted 6/17/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s or Master's degree in a scientific, technical, or information systems-related discipline (e.g., life sciences, engineering, computer science, or equivalent experience)
Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment
Demonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systems
Proven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioning
Working knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated state
Strong proficiency with Microsoft 365 and system reporting tools
Experience supporting internal audits and regulatory inspections as a system SME
Ability to travel occasionally (up to ~10%) as required for system support or inspections.

Benefits

Comp & perks

This is a remote opportunity with occasional travel, estimated at less than 10%.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

system administrationGxP systemssystem validationchange controlconfiguration managementissue triagetroubleshootingreporting toolsvalidation documentationrisk-based validation

Soft Skills

technical supportcommunicationcollaborationproblem-solvingattention to detailorganizational skillsleadershiptrainingcustomer serviceadaptability