Systems Administrator, Electronic GxP Systems

<p><strong>This is a remote opportunity with occasional travel, estimated at less than 10%.</strong></p> <p>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.</p> <p>The <strong>Systems Administrator, Electronic GxP Systems</strong> 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.&nbsp; The position serves as the hands-on technical authority for electronic quality systems, including MasterControl and other systems &amp; applications, and ensures these systems remain in a state of control throughout their lifecycle.</p> <p>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.&nbsp;</p> <p><strong>As Systems Administrator, Electronic GxP Systems you will:</strong></p> <ul> <li>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</li> <li>Maintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownership</li> <li>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</li> <li>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)</li> <li>Configure, maintain, and execute system workflows and forms, metadata and taxonomy structures, user roles, permissions, and security models</li> <li>Controlled system changes in accordance with validation requirements&nbsp;</li> <li>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)</li> <li>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</li> <li>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</li> <li>Ensure all system changes, upgrades, and enhancements follow approved change control and validation procedures</li> <li>Maintain inspection-ready validation documentation at all times.&nbsp;</li> <li>Develop, maintain, and execute system-level reports while ensuring system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+)</li> <li>Serve as a system subject matter expert (SME), including back-room inspection support and direct system demonstrations as required&nbsp;</li> <li>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</li> <li>Participate in industry forums, user groups, and training related to electronic GxP systems and validation best practices</li> </ul> <p><strong>A successful Systems Administrator, Electronic GxP Systems will demonstrate:</strong></p> <ul> <li>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</li> <li>Demonstrated expertise in data integrity principles (ALCOA+) and their application with electronic systems</li> <li>Ability to assess GxP impact and apply appropriate controls for GxP-supporting systems</li> <li>High technical judgement in executing system changes while maintaining compliance and inspection readiness</li> <li>Excellent analytical and problem-solving skills, with the ability to troubleshoot system issues and implement effective, compliant solutions</li> <li>Strong written and verbal communication skills, particularly when explaining system functionality and compliance concepts to non-technical users</li> <li>Ability to manage multiple system activities and priorities independently while maintaining accuracy, traceability, and quality</li> <li>Detail-oriented, execution-focused mindset with a demonstrated record of reliable follow-through</li> <li>Comfortable operating as an individual contributor in a regulated environment with clear accountability for system execution.&nbsp;</li> </ul> <p><strong>To be considered for the position, you must have:</strong></p> <ul> <li>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)</li> <li>Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment</li> <li>Demonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systems</li> <li>Proven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioning</li> <li>Working knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated state</li> <li>Strong proficiency with Microsoft 365 and system reporting tools</li> <li>Experience supporting internal audits and regulatory inspections as a system SME</li> <li>Ability to travel occasionally (up to ~10%) as required for system support or inspections</li> </ul>