Quality Assurance Senior Manager

2 days ago


Dublin, Dublin City, Ireland Amgen Full time

**Job Summary**

Amgen is seeking a highly experienced Quality Assurance Senior Manager to lead the representation, communication, and management of quality issues with internal and external partners. This role will serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition related to Amgen products.

The ideal candidate will have significant experience in small molecule or aseptic manufacturing, with a strong background in regulatory compliance and quality management. They will be responsible for managing CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety, and regulatory requirements.

The selected individual will also provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs, ensuring GMP compliance. Additionally, they will contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers.

**Key Responsibilities:**

  • Lead the representation, communication, and management of quality issues with internal and external partners
  • Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition
  • Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety, and regulatory requirements
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs
  • Contribute to the successful outcome of all regulatory inspections associated with company business

Requirements:

  • Doctorate degree & 2 years of directly related experience OR Master's degree & 4 years of directly related experience OR Bachelor's degree & 6 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
  • 10 + years biotech or pharmaceutical industry experience
  • Qualified Person status is desirable


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