GxP Systems and Support Administrator
About the role
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a GxP Systems and Support Administrator based in United States. The GxP Systems and Support Administrator will oversee the lifecycle administration and technical support of regulated GxP and Quality systems. You will help maintain critical platforms such as eQMS, CMMS, and digital validation applications in a compliant and validated state. The role combines hands-on systems administration, quality processes, cybersecurity, validation, and technical troubleshooting within an integrated IT environment. You will collaborate closely with Information Security, Quality, Digital, vendors, and cross-functional teams to ensure systems remain secure, reliable, and inspection-ready. Your work will directly support regulatory compliance, operational continuity, and the successful delivery of technology-enabled services. You will also contribute to system implementations, upgrades, audits, investigations, and continuous improvement initiatives. This is an opportunity to make a meaningful impact in a highly regulated environment where precision, documentation, and technical excellence are essential.
Responsibilities
- Administer GxP applications and supporting infrastructure, including eQMS, CMMS, and digital validation platforms, while ensuring systems remain reliable, secure, compliant, and fit for purpose throughout their lifecycle.
- Manage user accounts, role-based access controls, SSO and SCIM integrations, periodic access reviews, and entitlement processes to maintain appropriate system access.
- Configure systems and coordinate upgrades, patches, and other technical changes through established change control and validation procedures, ensuring the validated state is maintained.
- Deploy and manage project-based instances of digital validation applications to support client-facing services and operational requirements.
- Support Computer Software Assurance activities by reviewing vendor testing packages, performing documented ad hoc testing, executing System Acceptance Testing and User Acceptance Testing, and conducting periodic reviews.
- Create, review, and support the approval of validation documentation, SOPs, work instructions, training materials, system requirements, and technical documentation.
- Participate in risk assessments and validation impact assessments, and execute and document system change controls in accordance with Quality Management System requirements.
- Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues, providing technical analysis and appropriate corrective actions.
- Support CAPA investigations and contribute technical expertise to the identification and implementation of effective corrective and preventive measures.
- Provide technical support during internal and external audits, supplier audits, customer audits, and regulatory inspections, ensuring systems and documentation are inspection-ready.
- Ensure audit trails, electronic records, and electronic signatures are appropriately maintained and aligned with applicable regulatory requirements.
- Collaborate with software vendors to investigate defects, resolve technical issues, and implement