Regulatory Compliance Lead

Há 4 dias


Lisboa, Lisboa, Portugal Amgen SA Tempo inteiro

About Amgen SA:

We're a leading biotechnology company driven by our mission to serve patients. With a strong commitment to innovation and excellence, we strive to deliver high-quality treatments and therapies that make a difference in people's lives.

Our Global R&D Quality organization plays a crucial role in ensuring the highest standards of quality and compliance in our research and development processes. As part of this team, you'll have the opportunity to work on challenging projects, collaborate with talented professionals, and contribute to the success of our organization.

R&D Quality Senior Manager Role Overview:

This role is responsible for ensuring compliance with regulatory standards and coordinating cross-functional teams for global Regulatory Health Authority inspections. The successful candidate will have extensive experience in inspection management within the pharmaceutical or biotechnology industry and strong knowledge of global regulatory requirements and inspection processes.

Key Responsibilities:

  • Pre-Inspection Preparation
  • Develop and maintain inspection readiness plans, ensuring that all necessary information and resources are available.
  • Coordinate with cross-functional teams to ensure that all stakeholders are informed and prepared for inspections.
  • Inspection Management
  • Lead the development of inspection management plans, taking into account relevant regulatory requirements and business needs.
  • Manage the R&D inspection framework, including calendars, distribution lists, and SharePoint sites.
  • Collaboration and Communication
  • Work closely with R&D Quality TA Leads to develop inspection resourcing and facility plans.
  • Provide proactive advice and guidance on inspection management to colleagues and stakeholders.

Requirements:

  • Degree Educated
  • 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.
  • Proven ability to work effectively in a cross-functional team environment.
  • Strong organizational and project management skills.
  • Experience with SharePoint and other inspection management tools.
  • Ability to travel domestically and/or internationally as needed.

Why Choose Amgen SA?

  • Opportunities for professional growth and development.
  • A diverse and inclusive work environment.
  • A comprehensive Total Rewards Package.
  • Flexible working arrangements.


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