Audits :
- Monitor and conduct internal and external audits, GcP experience required,
- Issue annual audit plan,
- Feed partners management by establishing robust KPI
Suppliers
- Manage Quality Agreement, liaise with MSA
- Part of supplier selection, proactive in supplier qualification in case of urgent needs,
Partners and Vendors:
- Support and develop Sponsor oversight culture,
- QA counterpart for partners (LianBio)
Monitor our CMO partner from a QA perspective :
- Follow up reports and investigation,
- Quality agreement update, technical documentation related to the CE Mark,
- Support and contribute to specific SOP, such as Visual Inspection
- Manage gamma sterilization step
Expertise in “external” QA in suppliers, vendors management,
Project oriented,
Sense of efficiency across kpi’s management,
Strong knowledge in reglementation, both in GMP and MDR
Qualified as “auditor”