Group Administrator: Regulatory and Quality Applications

Role Overview

The Group Administrator for Regulatory and Quality Applications serves within the Group Digital Technology sector, focusing on daily operational support for regulatory and quality systems, primarily Veeva and associated platforms such as Esko Pulse, TVT, Argus PV, and Track wise Digital. This position is crucial for ensuring effective and compliant use of regulatory IT tools by the Regulatory Affairs department. Responsibilities include first-level user support, issue resolution, incident and request management, in collaboration with internal application analysts, IT teams, and external vendors like Veeva to resolve problems promptly.

Key Responsibilities

• Deliver first and second line assistance for users of regulatory software, including modules like Registrations, Submissions, Archive, CRM, and Safety.
• Monitor and resolve incident tickets, service requests, and changes, ensuring all service level agreements (SLAs) are met.
• Troubleshoot document upload errors, user access difficulties, metadata inconsistencies, and workflow faults.
• Manage user account creation, access permissions, and conduct compliance audits of roles and access rights.
• Coordinate incident escalations and maintain communication via ticketing systems such as ServiceNow.
• Conduct system health checks daily and analyze system logs and usage data to proactively address potential issues.
• Maintain comprehensive documentation including troubleshooting guides and FAQs; assist with user training and support material development.
• Assist in evaluating software releases, perform testing of new features, and verify system functionality ahead of deployments.
• Gather end-user feedback to recommend system improvements and participate in projects related to system enhancements and integrations.

Qualifications and Skills

• Bachelor’s degree in Computer Science, IT, Life Sciences, or a related discipline is mandatory.
• Veeva Vault certification required; ITIL Foundation certification is advantageous.
• Minimum of three years’ experience administering regulatory, quality, or similar GxP-validated applications.
• Comprehensive understanding of GxP regulations, Computer System Validation (CSV), and FDA 21 CFR Part 11 compliance requirements.
• Experience with eQMS platforms (notably Veeva QMS), Regulatory Information Management Systems (RIMS), document control tools (e.g., SharePoint DMS, Veeva Qdocs, OpenText), and Audit & Compliance software.
• Knowledge of system validation documentation such as URS, IQ/OQ/PQ, and traceability matrices.
• Skilled in workflow configuration, role-based security, and reporting functions within regulated environments.
• Familiarity with application support processes involving incident, problem, change, and request management conforming to ITIL practices.
• Excellent analytical, problem-solving, communication skills, and a capability to work cooperatively with cross-disciplinary teams.
• High discipline in documentation, configuration controls, and maintaining system integrity under audit conditions.

Additional Information

The role demands a proactive and dependable individual, capable of managing pressure effectively, especially during audits. A thorough understanding of regulatory affairs along with quality management processes is critical. Knowledge of integrations between enterprise systems like Veeva, SAP, and Argus is advantageous. The incumbent must maintain a validated system environment free from deviations and ensure all support activities follow GxP and CSV guidelines.