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Systems Administrator, Electronic GxP Systems at Kaléo. . Location: Remote. 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 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. . . A successful Systems Administrator, Electronic GxP Systems will demonstrate:. . . Strong working knowledge of applicable regulations and standards related to electronic GxP systems, including 21 CFR Parts 11, 210, 211, 820/QMSR, ISO 13485 and applicable ICH guidance. . Demonstrated expertise in data integrity principles (ALCOA+) and their application with electronic systems. . Ability to assess GxP impact and apply appropriate controls for GxP-supporting systems. . High technical judgement in executing system changes while maintaining compliance and inspection readiness. . Excellent analytical and problem-solving skills, with the ability to troubleshoot system issues and implement effective, compliant solutions. . Strong written and verbal communication skills, particularly when explaining system functionality and compliance concepts to non-technical users. . Ability to manage multiple system activities and priorities independently while maintaining accuracy, traceability, and quality. . Detail-oriented, execution-focused mindset with a demonstrated record of reliable follow-through. . Comfortable operating as an individual contributor in a regulated environment with clear accountability for system execution. . . . To be considered for the position, you must have:. . . 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.