Group Administrator: Regulatory and Quality Applications

Group Administrator: Regulatory and Quality Applications

Veeva

Job Requirements

• Bachelor’s degree in computer science, Information Technology, Life Sciences, or related field.
• ITIL Foundation (a plus).
• Veeva Vault certification (required).
• 3+ years administering Regulatory, Quality, or other GxP‑validated systems.
• Strong knowledge of GxP / CSV / 21 CFR Part 11
• Experience supporting one or more of the following highly desirable:
• eQMS platforms (Veeva QMS)
• RIMS systems
• Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText)
• Audit & Compliance applications
• Experience maintaining validated systems (URS, IQ/OQ/PQ, trace matrices).
• Familiarity with workflow design, role‑based security, reporting tools, and configuration rules
• Strong understanding of GxP requirements, data integrity, ALCOA+, and validation processes.
• Experience analysing and interpreting regulatory guidelines and applying them to system operations.
• Strong knowledge of role-based access administration and security controls.
• Application configuration, workflow administration, and user access management.
• Incident, problem, change, and request management using ITIL frameworks.
• Strong analytical and troubleshooting capability for application and workflow issues.
• Documentation discipline, including SOPs, work instructions, validation artefacts, and system logs.
• Ability to work collaboratively with Quality, Regulatory, and cross-functional stakeholders.
• Strong analytical and methodical problem‑solving skills.
• High attention to detail and disciplined approach to documentation and configuration control.
• Excellent communication skills, particularly in translating system concepts into business language.
• Ability to remain calm and effective under pressure or audit conditions.
• Proactive, collaborative, and committed to continuous improvement.
• High level of accountability and ownership of allocated tasks.
• Deep understanding of Regulatory Affairs and Quality Management processes.
• Knowledge of eQMS, RIMS, Document Control, and Audit & Compliance systems.
• Strong understanding of validation lifecycle, SOP standards, and compliance frameworks.
• Knowledge of integration patterns between enterprise systems (e.g., Veeva, SAP, Argus).
• Understanding of electronic records/e-signature regulations and data integrity requirements.

Application Support and Troubleshooting

• Provide 1st and 2nd line support for users of the Regulatory applications, E.g. Registrations, Submissions, Archive, CRM and Safety.
• Monitor support queues, investigate and resolve incidents, log service requests, and ensure timely follow-up and closure.
• Troubleshoot common issues such as document upload failures, user access problems, metadata mismatches, and workflow errors.
• Ensure SLAs are met, and tickets are closed on time (Incidents, Requests, Change & Problem)
• Ensure Problem Management is followed, and RCA is provided for major & recurring incidents
• Follow GxP & CSV methods and ensure system stays in validated state with no deviations

User Access Management

• Manage user onboarding/offboarding, access rights, and role-based permissions in compliance with internal SOPs.
• Assist with system audits of user access and role reviews to ensure regulatory compliance.

Incident Management & Escalation

• Collaborate with other team members, management, and service providers to escalate and resolve complex technical issues.
• Track and manage open issues using ticketing tools (e.g., ServiceNow), ensuring timely updates and user communication.

System Monitoring & Maintenance

• Perform daily health checks and monitor system performance to ensure uptime and data integrity.
• Track usage metrics, system logs, and user behaviour to proactively identify potential issues.

Documentation & Training

• Maintain system support documentation including troubleshooting guides, FAQ articles, and job aids.
• Assist in user training sessions and creation of quick reference materials to improve adoption and reduce support requests.

Release Readiness & Testing

• Review release notes (E.g. Veeva Release notes) and assist in testing new features and updates.
• Support quarterly releases by validating critical functionality and reporting potential issues before go-live.

Continuous Improvements

• Collect feedback from end-users to identify pain points and suggest system enhancements.
• Participate in projects related to system upgrades, enhancements, or integrations (e.g., with Argus, ERP, or EDMS systems).
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