External Quality Lead for CMO Compliance & Release

Amgen Inc. (IR); Dublin; On-site; EUR 91,000 - 123,000; Full time

Job summary

Amgen Dun Laoghaire–Dublin is seeking a Senior Manager External Supply to lead quality activities for contract manufacturing and CMOs. You will be the primary Quality contact for deviations, change controls, CAPAs, and batch disposition, ensuring adherence to quality agreements and regulatory requirements.

You will manage external manufacturing partners, review CMO documentation, and provide quality oversight during manufacturing, testing and release.

Qualifications

• 10+ years' biotech or pharmaceutical industry experience.
• Experience with aseptic manufacturing facilities.
• QP eligibility desirable.
• Ability to influence senior stakeholders and partners.
• Strong project management, problem-solving, and analytical skills.
• Demonstrated ability to lead cross-functional teams.

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Serve as main Quality point of contact for deviations, change controls, CAPAs and batch disposition.
• Manage CMOs to contractual Quality obligations and regulatory requirements.
• Review production batch records and approve master batch records and other cGMP documents.
• Provide quality oversight of manufacturing, testing, and release at CMOs.
• Facilitate communications between CMO and Amgen staff on deviations, changes, and batch disposition.
• Represent Quality activities on Amgen project teams and during inspections.

Skills

Biotech/pharma experience

Quality management

Project management

Stakeholder management

Data integrity

Cross-functional leadership

Education

Bachelor's degree in a scientific field

Tools

Project management tools

Job description

Amgen Dun Laoghaire–Dublin is seeking a Senior Manager External Supply to lead quality activities for contract manufacturing and CMOs. You will be the primary Quality contact for deviations, change controls, CAPAs, and batch disposition, ensuring adherence to quality agreements and regulatory requirements.

You will manage external manufacturing partners, review CMO documentation, and provide quality oversight during manufacturing, testing and release.