Quality Management Director

Há 7 dias


Lisboa, Lisboa, Portugal Amgen Inc. (IR) Tempo inteiro

Amgen Inc. (IR) is seeking a highly skilled R&D Quality Senior Manager to ensure our organization's compliance with regulatory standards and prepare for Regulatory Health Authority inspections globally.

About the Role

This vital position plays a crucial part in ensuring our organization's compliance with regulatory standards and preparing for Regulatory Health Authority inspections globally.

  • Develop inspection management plans for each identified Regulatory Health Authority inspection.
  • Manage the R&D inspection framework, including calendars, distribution lists, inspection notifications, SharePoint sites, training content, and more.
  • Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing and scaling across time zones.

Responsibilities:

  • Evaluate inspection preparation activities to ensure storyboards are developed for key processes and activities.
  • Organize presentations of storyboards and mock interviews in preparation for potential Sponsor inspections.
  • Serve as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management.

Requirements:

  • Degree-educated professional with extensive experience in inspection management within the pharmaceutical or biotechnology industry.
  • Strong knowledge of global regulatory requirements and inspection processes.
  • Excellent communication and presentation skills.

We Offer:

  • A diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.
  • Generous Total Rewards Plan comprising health, finance, work-life balance, and career benefits.

Apply Now:

At Amgen, we are committed to developing treatments that take care of others, while also caring for our teammates' professional and personal growth and well-being.



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