Senior Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €102,531 - €154,776
Quality Compliance Senior Manager

Description:

We are seeking a senior professional to lead our quality compliance efforts. This role will be responsible for ensuring the site is inspection-ready at all times, collaborating with cross-functional teams, and representing the site on global networks.

Responsibilities:

  1. Develop and maintain a perpetual state of inspection readiness.
  2. Collaborate with functional areas and across Amgen in preparation for inspections.
  3. Perform site inspection readiness efforts, including strategy sessions and pressure tests.
  4. Participate in inspections that may require direct/indirect interaction with regulators.
  5. Lead response and improvement actions resulting from Regulatory Agency and/or Business Partner inspections.
  6. Represent site and Regulatory Compliance function on global networks.
  7. Provide leadership toward resolving site and multi-site compliance risks.

Requirements:

  • Bachelor's degree in Life Sciences or Engineering.
  • 7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems.
  • Thorough understanding of quality management systems and quality control processes related to bulk drug, drug/combination product and finished product for clinical and commercial operations.

Benefits:

In addition to the base salary, we offer competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

About Us:

We are a global leader in biotechnology, dedicated to developing treatments that take care of others.

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