Group Administrator: Regulatory and Quality Applications
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Key skills for this role
About the Role
Responsible for application support and user assistance for Regulatory and Quality Applications, requiring strong knowledge of GxP, Veeva systems, and incident management.
Key Skills for This Role
Responsibilities
- Provide 1st and 2nd line support for users of Regulatory applications (Registrations, Submissions, Archive, CRM, Safety)
- Monitor support queues, investigate and resolve incidents, log service requests, ensure timely follow up and closure
- Manage user onboarding/offboarding, access rights, and role based permissions in compliance with internal SOPs
- Collaborate with team members, management, and service providers to escalate and resolve complex technical issues
- Perform daily health checks and monitor system performance to ensure uptime and data integrity
- Maintain system support documentation including troubleshooting guides, FAQ articles, and job aids
- Assist in user training sessions and creation of quick reference materials
- Review release notes and assist in testing new features and updates
- Collect feedback from end users to identify pain points and suggest system enhancements
Requirements
- Bachelor’s degree in computer science, Information Technology, Life Sciences, or related field
- Veeva Vault certification (required)
- 3+ years administering Regulatory, Quality, or other GxP validated systems
- Strong knowledge of GxP / CSV / 21 CFR Part 11
- 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
- Strong knowledge of role based access administration and security controls
- Incident, problem, change, and request management using ITIL frameworks
- Strong analytical and troubleshooting capability for application and workflow issues
Full Job Posting
Role Overview
- The Group Administrator: Regulatory and Quality Applications is an operational role in the Group Digital Technology team, responsible for providing day to day application support, issue resolution, and user assistance for the Regulatory and Quality Application which includes primarily Veeva and rela
- This role is support focused, ensuring that Regulatory Affairs teams can operate efficiently and in compliance using the Regulatory IT platforms.
- The Administrator acts as a first line of support for users, manages incidents, service requests and changes, coordinates with internal Regulatory Application Analyst / Specialist, Internal IT Teams and Vendor (like Veeva) for issue escalation, and plays a critical role in maintaining system stabili
- Basic Veeva system configuration and reporting skills are essential.
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.
Key Performance Areas (KPA)
- 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 behavior to proactively identify potential issues.
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