Clinical Supply Chain Manager - Change Control And Deviations

Amgen UK

Hyderabad, India
Change control records management
Deviation records management
Capa records management
In this vital role, 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 in ABR and ATO

Job Summary

  • In this vital role, 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 in ABR and ATO.
  • You will provide people leadership and operational oversight for the Study Setup Support Office, and as the owner of Compliance Records you will partner closely with key stakeholders across Operations, Clinical Quality, R&D, and the change control team in ABR.
  • 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.

Matching Summary

In this vital role, 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 in ABR and ATO.

Skills & Requirements

Must-have

  • Change Control Records Management
  • Deviation Records Management
  • CAPA Records Management
  • Clinical Product Life Cycle Changes
  • Study Design Setup deliverables
  • GMP and GDP adherence

Nice-to-have

  • People leadership and team development
  • Continuous improvement initiatives
  • Operational rigor and process discipline
  • Patient-centric mindset
  • AI adoption for productivity

Key Requirements

  • Bachelor degree or equivalent
  • 5 years relevant working experience
  • 3 years project leadership experience
  • Advanced MS Office applications
  • Fluency in English

Work Rights

Not specified

Tailored Resume

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