- Ensure customer complaints are independently investigated, documented, and communicated to stakeholders.
- Triage and route complaints to appropriate third parties based on product and dispensing location.
- Evaluate third-party pharmacy investigation reports for root cause analysis and quality standards.
- Determine regulatory reportability of events under 503A/503B classification and FDA requirements.
- Track complaint deadlines against contractual and regulatory timelines.
- Analyze complaint trends across categories like packaging and cold chain to recommend process changes.
- Create and present metric reports on complaint trends, root cause analysis, and action plans to leadership.
- Lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, and medical affairs.
ComplianceQuality AssuranceZendesk