[Remote] Systems Administrator, Electronic GxP Systems

Note: The job is a remote job and is open to candidates in USA. 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 responsible for ensuring that electronic GxP systems remain validated and compliant, serving as the technical authority for these systems. This role involves maintaining system integrity, supporting quality assurance processes, and collaborating with IT and system owners to ensure compliance with regulatory requirements.

Responsibilities

• 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

Skills

• 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
• 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

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