- Dublin, Leinster, Ireland
- Hybrid
- Contract · Manager
Senior Manager, Qualified Person
Responsibilities
- Perform EU Qualified Person duties in accordance with Directive 2001/83/EC and Annex 16 requirements for EU/EEA and global markets
- Provide expert guidance to Quality Operations teams supporting batch certification activities
- Support investigations through FIT, FIRM and Product Review Committee processes
- Partner with launch excellence, supply chain and manufacturing teams to support new product introductions and market launches
- Participate in regulatory inspections, corporate audits, recalls and competent authority notifications
Requirements
- MSc (or equivalent) in a scientific, technical or related discipline