Clinical Supply Chain Manager - Change Control And Deviations
Amgen
Hyderabad, India
Change control records management
Deviation records management
Capa records management
You will serve as the Manager Clinical Supply Chain, managing Compliance Records related to Clinical Product Life Cycle Changes (Change Control, Deviations and CAPA’s) as record owner, and in addition leading a team of two Senior Associates supporting Study Design Setup deliverables across the global team
Job Summary
You will serve as the Manager Clinical Supply Chain, managing Compliance Records related to Clinical Product Life Cycle Changes (Change Control, Deviations and CAPA’s) as record owner, and in addition leading a team of two Senior Associates supporting Study Design Setup deliverables across the global team.
The role is accountable for managing efficient and effective execution of study setup (GMP) deliverables, such as Depot Plans, Product Specification Files and Master data requests.
Partner with Global Clinical Supply Chain, Clinical Study Teams, Quality and Regulatory Affairs to translate global priorities into actionable local plans and ensure execution in compliance with all applicable regulatory guidelines and Amgen procedures.
Matching Summary
You will serve as the Manager Clinical Supply Chain, managing Compliance Records related to Clinical Product Life Cycle Changes (Change Control, Deviations and CAPA’s) as record owner, and in addition leading a team of two Senior Associates supporting Study Design Setup deliverables across the global team.