Inspection Management Specialist

Há 5 dias


Lisboa, Lisboa, Portugal Amgen Sa Tempo inteiro

**About the Role:**

The R&D Quality Senior Manager will play a vital part in ensuring our organization's compliance with regulatory standards and preparing cross-functional teams for Regulatory Health Authority inspections globally.

**Key Responsibilities:**

  • Develop and implement inspection management plans for each identified Regulatory Health Authority inspection.
  • Manage the R&D inspection framework, including calendars, distribution lists, and SharePoint sites.
  • Liaise with R&D Quality TA Leads to ensure appropriate inspection resourcing and alignment across time zones.
  • Evaluate and mitigate potential inspection findings and compliance risks.

**Requirements:**

  • Proven experience in regulatory compliance and inspection management.
  • Excellent communication and leadership skills.
  • Ability to work effectively in a global team environment.
  • Familiarity with GCP regulatory inspections and quality oversight processes.


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