Senior External Quality Manager – CMO Oversight

Biopharma Careers; Dublin; On-site; EUR 91,000 - 123,000; Full time

Job summary

Amgen Dun Laoghaire - Dublin seeks a Senior Manager External Supply to lead quality activities in contract manufacturing for Amgen products. You will act as main quality contact for deviations, change controls, CAPAs, and batch dispositions, and manage CMOs to meet quality agreements and regulatory requirements.

Role requires extensive experience in biotech/pharma quality, ability to lead cross-functional teams, and ensure product release readiness across CMOs.

Qualifications

• 10+ years biotech/pharmaceutical quality experience.
• Significant QA experience at aseptic manufacturing facilities.
• Able to influence senior stakeholders and drive alignment with partners.

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 obligations related to Quality Agreement, specifications, quality, safety and regulatory requirements.
• Review production batch Records and approve Master Batch Records and other cGMP documents from CMOs/Contract Labs.
• Provide quality oversight of manufacturing, testing and release of Amgen products at CMOs.
• Facilitate communication on deviations, change controls, complaints and batch disposition between CMO and Amgen staff.
• Engage with Quality, Production, Regulatory and Logistics teams at CMO sites during scheduled meetings.

Skills

Quality leadership

Cross-functional

cGMP knowledge

Deviation & CAPA

CMO management

Regulatory readiness

QP eligibility

Project management

Job description

Amgen Dun Laoghaire - Dublin seeks a Senior Manager External Supply to lead quality activities in contract manufacturing for Amgen products. You will act as main quality contact for deviations, change controls, CAPAs, and batch dispositions, and manage CMOs to meet quality agreements and regulatory requirements.

Role requires extensive experience in biotech/pharma quality, ability to lead cross-functional teams, and ensure product release readiness across CMOs.