Group Analyst: Regulatory and Quality Applications (Dubai)
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Key skills for this role
About the Role
Aspen Holdings is seeking a Group Analyst for Regulatory and Quality Applications to administer, configure, and support systems like eQMS, RIMS, Document Control, and Audit & Compliance platforms.
Key Skills for This Role
Responsibilities
- 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 upgrades/releases as per Vendor quarterly release cycles
- Work on minor enhancement/backlog initiatives for regulatory applications
- Conduct routine system checks, maintenance tasks, and support validated state upkeep
- Ensure systems are available and functioning for Quality and Regulatory processes
- Support data integrity controls including audit trails, electronic signatures, and controlled documents
- Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments
- Support internal/external audits, inspections, and regulatory reviews
- Provide Tier 2 and 3 support for application issues
- Develop and deliver user training, onboarding materials, and system guides
Requirements
- Bachelor's degree in Computer Science, Information Technology, Life Sciences, or related field
- ITIL Foundation certification (required)
- Veeva Vault certification (required)
- 3 5+ years administering Regulatory, Quality, or other GxP validated systems
- Experience with eQMS platforms (Trackwise, Veeva QMS, Esko Pulse) highly desirable
- Experience with RIMS systems highly desirable
- Experience with Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText) highly desirable
- Experience with Audit & Compliance applications highly desirable
- Experience maintaining validated systems (URS, IQ/OQ/PQ, trace matrices)
- 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
- Strong analytical and troubleshooting capability
Full Job Posting
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.
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.
- Strong analytical and troubleshooting capability for application and workflow issues.
- Documentation discipline, including SOPs, work instructions, validation artefacts, and system logs.
KPA: 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 upgrades/releases as per Vendor quarterly release cycles.
- Work on minor enhancement/backlog initiatives for regulatory applications, i.e. building of custom report, deployment of Single Sign On or a new security policy.
- Conduct routine system checks, maintenance tasks, and support validated state upkeep.
KPA: 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.
KPA: 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.
KPA: 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.
KPA: 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.
KPA: 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).
KPA: 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.
KPA: 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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