Group Analyst: Regulatory and Quality

Job Purpose

Operational role within the Group Digital Technology team responsible for the administration, configuration, and support of systems used for regulatory, quality, and compliance operations across the organization. The Group Analyst serves as an application specialist supporting enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools. The role ensures systems are maintained in a validated state, operated securely, and aligned with global regulatory standards, including GxP, 21 CFR Part 11, ISO 9001, and ISO 13485.

The incumbent supports the Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes while working with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement.

• 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.
• Lead system upgrades/releases per vendor quarterly release cycles.
• Build custom reports, implement Single Sign‑On and new security policies.
• Conduct routine system checks, maintenance tasks, and support validated state upkeep.
• Ensure systems are available and functioning for Quality and Regulatory processes (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.
• Maintain validation documentation (URS, IQ/OQ/PQ, change controls, risk assessments).
• Support internal and external audits, inspections, and regulatory reviews.
• Provide Tier 2 and Tier 3 support for application issues, escalating to managers, vendors, or IT infrastructure as necessary.
• Troubleshoot workflow failures, configuration errors, access issues, and data inconsistencies.
• Develop and deliver user training, onboarding materials, and system guides.
• Communicate system updates, enhancements, and release impacts to end users.
• Coordinate with vendors for issue resolution, small changes, and enhancement support.
• Track software licences, renewals, and small system contracts.
• Generate reports, dashboards, metrics, and compliance indicators.
• Monitor system performance, availability, and incident trends.
• Contribute to continuous improvement initiatives to enhance system reliability.
• Promote consistent global usage of Regulatory & Quality systems.

• 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 eQMS platforms (Trackwise, Veeva QMS, Esko Pulse), RIMS systems, Document Control systems (SharePoint DMS, Veeva Qdocs, Open Text), 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.
• High attention to detail and disciplined approach to documentation and configuration…