Group Analyst: Regulatory and Quality Applications

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.

Desired Candidate Profile

• 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: o eQMS platforms (Trackwise, Veeva QMS, Esko Pulse) o RIMS systems o Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText) o 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.