Title: Associate Director, North America Quality & FDA Liaison
Location: New Brunswick, NJ
A leading pharmaceutical company is seeking a qualified candidate to support the North America Quality team for field alert reports, drug product recalls, and recall reports.
- Management of Field Alert Reports (FARs)
- Attendance of Global Recall Committee meetings
- Management of documentation and responses to/from the FDA, such as deviation reports
- Manager 3rd party service provider for product quality complaints
- Support NA region in terms of Quality Metrics and monitor action items for compliance improvement
- Advanced knowledge of FDA/regulatory drug regulations
- Experience interfacing with the FDA, with drug product recalls, and with field alert reporting
- 10 years experience within a regulated pharmaceutical industry in a Quality Assurance function
If you or anyone in your network is seeking an opportunity like this, please don't hesitate to apply!