Role Summary
Support enterprise QMS compliance through eQMS monitoring, data analysis, governance support, escalation management, and executive reporting. The role turns quality data into clear insights that improve accountability, reduce compliance risk, and enable more efficient, digitally supported oversight.
Basic Requirements
- Bachelor’s degree in Quality, Engineering, Business, Information Systems, Data Analytics, Life Sciences, or a related discipline.
- 2+ years of experience in quality systems, quality compliance, quality operations, regulatory compliance, data analytics, or a related field within a regulated environment.
- Hands-on experience working with an enterprise Quality Management Systems monitoring quality-system records, metrics, backlogs, or compliance performance.
- Advanced Excel and data-analysis skills, with demonstrated ability to develop dashboards, scorecards, executive reports, and clear presentations for leadership.
Preferred Requirements
- Power BI experience and exposure to reporting automation, digital transformation, or AI-enabled quality solutions.
- Knowledge of ISO 9001, GMP, FDA, Health Canada, or other applicable quality and regulatory requirements.
- Experience supporting global quality systems, enterprise compliance governance, or quality performance-management processes.
- Experience working in a shared-services or GBS environment.
Primary Focus Areas
- QMS compliance monitoring, overdue-item management, and escalation
- Quality dashboards, scorecards, trend analysis, and risk insights
- Governance coordination and management-review reporting
- Reporting automation, data quality, and digital-quality enablement
