Senior Quality Assurance Manager

Há 2 dias


Portugal Amgen Inc. (Ir) Tempo inteiro

About the Role

Amgen Inc. (Ir) is seeking a Senior Quality Assurance Manager to join our team in the Clinical Development department. As a key member of the R&D Process Quality team, you will play a vital role in ensuring the quality of our clinical development programs.

About Us

At Amgen, we are committed to serving patients living with serious illnesses. Our mission is to research, manufacture, and deliver innovative medicines that help people live longer, fuller lives. With a focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year.

Responsibilities

  • Create and maintain data tools to enable stakeholders to ensure quality in the R&D space.
  • Maintain Quality oversight related to continuous improvements (CI) associated with our Quality Management System (QMS) through metrics and key performance indicators (KPIs).
  • Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained).
  • Evaluate and implement quality standards and procedures to ensure compliance with regulatory requirements.

Requirements

The ideal candidate will have:

  • A bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Assurance).
  • Minimum 5 years of experience in Quality Assurance, preferably in a pharmaceutical industry.
  • Strong understanding of quality systems, including ISO 13485 and GxP regulations.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively as part of a cross-functional team.

What We Offer

As a Senior Quality Assurance Manager at Amgen, you will enjoy a competitive salary range of $140,000 - $180,000 per annum, depending on your level of experience and qualifications. Additionally, you will be eligible for our comprehensive benefits package, which includes medical, dental, and vision insurance, 401(k) matching, and paid time off.



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