[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.ResponsibilitiesServe 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 dataMaintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownershipEnsure 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 inspectionsServe 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 modelsControlled system changes in accordance with validation requirementsProvide 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 profileExecute 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 archivalEnsure all system changes, upgrades, and enhancements follow approved change control and validation proceduresMaintain inspection-ready validation documentation at all timesDevelop, 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 requiredProvide 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 impactParticipate in industry forums, user groups, and training related to electronic GxP systems and validation best practicesSkillsBachelor'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 environmentDemonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systemsProven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioningWorking knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated stateStrong proficiency with Microsoft 365 and system reporting toolsExperience supporting internal audits and regulatory inspections as a system SMEAbility to travel occasionally (up to ~10%) as required for system support or inspectionsStrong 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 guidanceDemonstrated expertise in data integrity principles (ALCOA+) and their application with electronic systemsAbility to assess GxP impact and apply appropriate controls for GxP-supporting systemsHigh technical judgement in executing system changes while maintaining compliance and inspection readinessExcellent analytical and problem-solving skills, with the ability to troubleshoot system issues and implement effective, compliant solutionsStrong written and verbal communication skills, particularly when explaining system functionality and compliance concepts to non-technical usersAbility to manage multiple system activities and priorities independently while maintaining accuracy, traceability, and qualityDetail-oriented, execution-focused mindset with a demonstrated record of reliable follow-throughComfortable operating as an individual contributor in a regulated environment with clear accountability for system executionCompany Overviewkaleo is a pharmaceutical company that develops combination drug products that empowers patients to control their medical conditions. It was founded in 2005, and is headquartered in Richmond, Virginia, USA, with a workforce of 51-200 employees. Its website is https://kaleo.com/.