Kaleo Software

System Administrator

• 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

Systems Administrator, Electronic GxP Systems

Software Engineer

• Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485
• Lead and responsible for human factor engineering activities as per the regulatory guidelines
• Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget
• Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019
• Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities
• Help build Kaleo’s intellectual property portfolio
• Manage project and program budgets and timelines effectively
• Author and review regulatory submissions (as needed)
• Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs

Systems Administrator, Electronic GxP Systems

Director, Development and Human Factor Engineering