This is what you will do: Theprimary purpose of this position istobuildinternalQMSoversightforAI DHT orAISaMDdevelopmentwithbusinesspartneringAIDHT /AISaMDcompanies.
Thebusinesspartner(BP)shall develop thetechnologiesand shallexecute processes in line with their own QMS.TheBPshall also complete the regulatory submissions for theproductunless Alexiondecides to perform this role.TheDHTQshall ensure key quality criteria are in place in the Alexion QMS so that development work can start andoversee theBPdesign control activity to ensurekey quality milestones are achievedfor EU andUS markets.
TheDHTQis the quality liaison betweenDiagnostics Strategy