Senior Manager, External Quality & CMO Oversight

Amgen SA; Dún Laoghaire; On-site; EUR 110,000 - 140,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Manager External Supply to lead quality oversight of contract manufacturing for Amgen products. The role focuses on deviations, CAPAs, batch disposition, and regulatory interactions across CMOs, ensuring cGMP compliance.

The successful candidate will manage quality programs, lead cross-functional teams, and drive risk management and data integrity initiatives at the CMO sites, contributing to successful inspections and product release.

Qualifications

• 10+ years' biotech or pharmaceutical industry experience.
• Experience with aseptic manufacturing facilities and cGMP.
• QP eligibility desirable.
• Ability to influence senior stakeholders and manage timelines.
• Strong project management, problem-solving, and analytical skills.
• Experience with quality systems and regulatory inspections.
• Familiarity with variation management processes.

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing teams.
• Serve as main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contractual obligations related to quality, safety, 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 communication on deviations, change controls, complaints, and batch disposition with CMOs and Amgen staff.
• Meet with Quality, Production, Regulatory, and Logistics at CMO sites as needed.
• Represent Quality activities from CMO site on Amgen project teams.
• Support CMO site activities (NPI, tech transfer, PPQ, filings) per Quality Agreement.
• Ensure CMO Site has Data Integrity program and conduct DI assessments if needed.
• Represent Amgen at Regulatory inspections and Notified Body audits as presenter if required.
• Manage inspection readiness and prepare inspection playbooks.
• Represent Amgen as Person-In-Plant as applicable.
• Identify and mitigate risk at CMO or testing labs.
• Monitor and communicate site performance via quality metrics; escalate risks.
• Develop prioritization and escalation as needed; maintain strong CMO relationships.
• Collaborate across site, functional, and executive leadership.

Skills

Quality management

Project management

Stakeholder influence

Cross-functional leadership

Data Integrity

Regulatory knowledge

Risk management

Quality systems

Communication

Quality Assurance

Audit readiness

CAPA handling

Job description

Amgen Dun Laoghaire is seeking a Senior Manager External Supply to lead quality oversight of contract manufacturing for Amgen products. The role focuses on deviations, CAPAs, batch disposition, and regulatory interactions across CMOs, ensuring cGMP compliance.

The successful candidate will manage quality programs, lead cross-functional teams, and drive risk management and data integrity initiatives at the CMO sites, contributing to successful inspections and product release.