Group Analyst: Regulatory and Quality Applications

Job Purpose

Job Requirements

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or related field.
• ITIL Foundation (required).
• Veeva Vault certification (required).
• GxP / CSV / 21 CFR Part 11 training (preferred).
• 3-5+ years administering Regulatory, Quality, or other GxP‑validated systems.
• Experience supporting one or more of the following highly desirable:
• eQMS platforms (Trackwise, Veeva QMS, Esko Pulse)
• 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.
• Knowledge of FDA 21 CFR Part 11, EMA, ICH, and relevant global regulatory guidelines.
• 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.

System Administration & Configuration

• Perform day‑to‑day administration and configuration of Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms).
• Manage user accounts, roles, permissions, and security groups.
• Configure workflows, rules, fields, and metadata according to approved designs.
• Technical lead system upgrade’s/releases as per Vendor quarterly release cycles.
• Work on minor enhancement/backlog initiatives for regulatory applications, i.e. building of custom report, deployment of Sing-Sign-on or a new security policy.
• Conduct routine system checks, maintenance tasks, and support validated state upkeep.

Regulatory & Quality Support

• Ensure systems are available and functioning for Quality and Regulatory processes (e.g., submissions, CAPAs, audits, deviations, SOPs, training).
• Support data integrity controls including audit trails, electronic signatures, and controlled documents.
• Assist in execution of controlled changes following QA-approved processes.

Compliance, Validation & Documentation

• Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments.
• Support internal/external audits, inspections, and regulatory reviews.
• Ensure system documentation, SOPs, user guides, and training material remain updated.

Issue Resolution & User Support

• Provide Tier 2 and 3 support for application issues, escalating to Manager, vendors, or IT infrastructure where required.
• Troubleshoot workflow failures, configuration errors, access issues, and data inconsistencies.
• Ensure timely resolution of incidents in line with SLAs. Training & Change Management
• Develop and deliver user training, onboarding materials, and system guides.
• Communicate system updates, enhancements, and release impacts to end users.
• Promote consistent global usage of Regulatory & Quality systems.

Vendor & Stakeholder Coordination

• Coordinate with vendors for issue resolution, small changes, or enhancement support.
• Participate in requirements gathering and solution assessments.
• Track software licences, renewals, and small system contracts (supporting the Manager, not owning).

Data Governance & Reporting

• Ensure accuracy, consistency, and integrity of data across Regulatory & Quality systems.
• Generate reports, dashboards, metrics, and compliance indicators.
• Support analyses for audits, regulatory submissions, and management reviews.

Service Delivery & Monitoring

• Monitor system performance, availability, and incident trends.
• Contribute to continuous improvement initiatives to enhance system reliability.
• Support proactive identification of risks and potential issues.
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