The global position of Bio Manufacturing Science and Technology (MSAT) Quality Partner provides Quality expertise and ensures proper oversight, from a global quality perspective, ofthe MSAT activities associated with Internal and External Manufacturing of Bio DrugSubstances, Drug Products and corresponding Packaging.
Key responsibilities
Overseeing processes across brands and MSAT related investigations as well as second-linetroubleshooting, enabling technical transfers and continuous improvement programs. The rolewill ensure compliance with evolving regulatory requirements and that quality issues aremanaged with diligence, rigor and transparency.
This will be achieved through close partnering in an efficient and collaborative way withInternal and External Bio MSAT, Bio MSAT Quality, Supply Chain, IT, Regulatory, Internal andExternal manufacturing operations and other team leaders in External & Clinical SupplyQuality and within the Quality organization.
Provide expert QA advice, support and management for technical operational QA andgeneral QA matters associated with Internal & External Bio MSAT, with the following focus:
o Troubleshooting and ensure issues are resolved in accordance with policies andprocedures
o Process improvement and life cycle management strategy within regulatory fileboundaries
o Process industrialization and Technical transfers within commercial manufacturingfacilities
o Complex investigations and CAPA plans implementation
o Process validation oversight and continuous process verification (CPV)