Senior QA Lead, External Supply & CMOs

Amgen SA; Dún Laoghaire; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plans

Accommodations for applicants

Job summary

Amgen is seeking a senior Quality professional in Dublin to ensure the supply of high-quality products produced at contract manufacturers. You will lead quality governance across cross-functional teams, manage deviations and CAPAs, and oversee regulatory readiness for inspections and audits.

The role emphasizes collaboration with internal partners and CMOs, oversight of batch releases, and maintaining GMP compliance while supporting global launches and NPI activities.

Qualifications

• 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

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing team
• Lead representation, communication and management of quality issues with internal and external partners
• Serve as the main Quality point of contact for deviations, change controls, CAPAs, and batch disposition
• Manage CMOs to contractual obligations relative to Quality Agreement and regulatory requirements
• Review production batch records and approve master batch records and other cGMP documents
• Provide quality oversight of manufacturing, testing, and release of Amgen products at CMOs
• QA review of all documentation associated with batch release for GMP compliance
• Negotiate, author and approve quality agreements
• Lead inspection readiness and representation at regulatory inspections and Notified Body audits
• Contribute to successful regulatory inspections and present on topics
• Review/Approve Master Batch Records
• Prepare inspection playbooks
• Identify and mitigate risk at CMO or testing labs and escalate as needed
• Perform Person in Plant activities as required
• Provide Amgen Quality support for CMO site activities (NPI, tech transfer, PPQ, filings)
• Monitor site performances using quality metrics and communicate with Amgen and CMOs
• Identify prioritisation opportunities and determine escalation points
• Develop strong partnerships with CMOs and testing labs
• Manage submission-related activities at CMOs for international launches

Skills

Quality systems

Documentation & GMP

Cross-functional collaboration

Regulatory inspections

Education

PhD

MSc

Bachelors

Associate degree

High school diploma

Job description

Amgen is seeking a senior Quality professional in Dublin to ensure the supply of high-quality products produced at contract manufacturers. You will lead quality governance across cross-functional teams, manage deviations and CAPAs, and oversee regulatory readiness for inspections and audits.

The role emphasizes collaboration with internal partners and CMOs, oversight of batch releases, and maintaining GMP compliance while supporting global launches and NPI activities.