Systems Administrator, Electronic GxP Systems
Remote · United States
Job Summary
Systems Administrator, Electronic GxP Systems — remote opportunity with occasional travel. Serves as the hands-on technical authority for electronic GxP and GxP-supporting systems (e.g., MasterControl, TrackWise, Veeva, Documentum) to ensure validation, traceability, and defensibility across the system lifecycle. Responsibilities include maintaining inventory and classification for GxP impact, configuring workflows, user roles, and security; leading validation activities (IQ/OQ/PQ), change control, and inspection-ready documentation; providing day-to-day technical support, troubleshooting, and data integrity (ALCOA+) across QA systems; collaborating with IT and system owners on access controls and data protection; participating in audits and regulatory inspections; and contributing to industry forums and training. Qualifications emphasize deep experience with validated systems, ALCOA+ data integrity, risk-based validation, and strong communication skills; travel up to ~10% is required.
Required Qualifications
- Bachelor’s or Master’s degree in a scientific, technical, or information systems-related discipline
- 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%)
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