Systems Administrator, Electronic GxP Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the system administrator and execution lead for all electronic GxP systems and applications that are instrumental in creating, managing, storing, or reporting regulated quality data.

• Maintain a thorough and updated inventory of electronic GxP and GxP-supporting systems, detailing system purpose, GxP impact, validation status, and ownership.

• Ensure that all relevant systems are correctly classified for GxP impact, validated, and kept in a validated state, ensuring traceability to intended use and regulatory standards, and defensibility during audits and inspections.

• Serve as the primary or backup system administrator across multiple electronic systems platforms, including those supporting document control, training, change control, deviations, investigations, CAPA, audit, customer complaint workflows, electronic batch records, external submissions, and device history files.

• Configure, maintain, and execute system workflows, forms, metadata and taxonomy structures, user roles, permissions, and security models.

• Implement controlled system changes in accordance with validation requirements.

• Oversee quality system execution for GxP-supporting applications interfacing with or aiding GxP activities (e.g., reporting tools, repositories, workflow platforms, and validated interfaces).

• Collaborate with Information Technology and system owners to ensure proper procedures and documentation, controlled access and data protection, and change management in line with GxP risk profiles.

• Conduct and support system validation activities throughout the system lifecycle, including validation planning and impact assessments, IQ/OQ/PQ documentation, test execution, and maintenance and archival of validated evidence.

• Ensure that all system modifications, upgrades, and enhancements comply with approved change control and validation procedures.

• Keep inspection-ready validation documentation consistently available.

• Develop, maintain, and execute system-level reports while ensuring that system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+).

• Act as a system subject matter expert (SME), providing back-room inspection support and direct system demonstrations as necessary.

• Offer daily technical support for electronic GxP systems, including issue triage, troubleshooting, and resolution, while assessing new system features and tools to provide compliance and operational impact recommendations.

• Engage in industry forums, user groups, and training related to electronic GxP systems and validation best practices.

⛳️ Requirements

• Bachelor's or Master's degree in a scientific, technical, or information systems-related field (e.g., life sciences, engineering, computer science, or equivalent experience).

• A minimum of 6+ years of experience supporting Quality Assurance systems within a regulated pharmaceutical, biotechnology, medical device, or combination product environment.

• Proven hands-on experience managing electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or comparable quality systems.

• Demonstrated experience supporting validated system lifecycles, encompassing system implementation, configuration, change control, upgrades, and decommissioning.

• In-depth knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated states.

• Strong proficiency with Microsoft 365 and system reporting tools.

• Experience providing support during internal audits and regulatory inspections as a system SME.

• Willingness to travel occasionally (up to ~10%) as needed for system support or inspections.

🏝️ Benefits

• This position offers a remote opportunity with occasional travel, estimated at less than 10%.