Systems Administrator, Electronic GxP Systems - Kaleo

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

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.

The Systems Administrator, Electronic GxP Systems is a critical contributor to a high-performing Quality Assurance organization focused on building reliable, inspection-ready systems that support compliant execution at-scale. This role ensures that electronic GxP and GxP-supporting systems remain validated, traceable, and defensible, forming a stable digital foundation for quality oversight and decision-making. The position serves as the hands-on technical authority for electronic quality systems, including MasterControl and other systems & applications, and ensures these systems remain in a state of control throughout their lifecycle.

The ideal candidate is a hands-on technical expert with deep experience in validated systems, data integrity, and electronic quality tools, who thrives in execution and takes ownership of keeping systems in a continuous state of control. Operating in a regulated pharmaceutical and combination-product environment, this role enables teams to focus on risk, performance, and improvement – confident that the systems underpinning the work are sound.

As Systems Administrator, Electronic GxP Systems you will:

• 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 m