Quality Assurance Leader

1 week ago


Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeCompliance Full time €82,221 - €132,254

Ensure a Culture of Compliance and Drive Quality Excellence

Job Description:

As a Senior Manager, Inspection Lifecycle Management, you will be instrumental in ensuring the Amgen Dún Laoghaire site maintains a perpetual state of inspection readiness. This involves cross-functional collaboration, on-site presence, and leadership in generating formal response commitments.

You will lead the preparation for, execution of, and response to regulatory agency and business partner inspections. Your role requires expertise in establishing and maintaining best practice and effective inspection lifecycle processes, applying current regulations, standards, and guidelines, as well as SOPs.

The position may also involve serving as a Subject Matter Expert (SME) for GMP/GDP compliance topics, supporting the self-inspection program, and fulfilling regulatory requests and documentation related to the ADL site inspection/certification status.

Responsibilities and Deliverables:

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