QA Manager: Deviations & Quality Leadership

Amgen Inc. (IR); Dublin; On-site; EUR 76,000 - 103,000; Full time

Job summary

Amgen QA Manager Deviations role in Ireland leads a team of Quality professionals to ensure cGMP compliance, regulatory expectations and patient safety across manufacturing support. You will drive quality performance, inspection readiness, operational excellence, and continuous improvement through strong cross-functional partnership.

This position requires demonstrated leadership, expertise in deviations/investigations/CAPA/change controls, and the ability to influence across functions while

Qualifications

• Degree in Science, Engineering, Pharmacy, or related discipline.
• 7+ years in pharma/biotech with increasing responsibility.
• GMP quality systems expertise including deviations, investigations, CAPA and change controls.
• Experience supporting regulatory inspections and audit readiness.
• Excellent communication and stakeholder management.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead and develop a high-performing team of Quality professionals through recruitment, selection, training and development.
• Provide strategic and operational leadership for manufacturing deviations, ensuring compliance with cGMP, GDP, Amgen standards and global requirements.
• Oversee the Quality Management System processes: deviations, investigations, CAPAs, change controls and related assessments.
• Provide quality leadership and risk-based decisions for complex issues, escalating significant risks as needed.
• Partner cross-functionally with Manufacturing, Engineering, Validation, Quality Control, Supply Chain and others.
• Lead inspection readiness activities and represent QA during audits and governance forums.
• Monitor quality system performance and drive continuous improvement and operational effectiveness.
• Support implementation of site and global quality strategies, driving simplification and standardization.
• Promote EH&S and sustainability requirements to maintain a safe, compliant workplace.

Skills

Leadership

GMP knowledge

Cross-functional

Regulatory inspections

Communication skills

Analytical skills

Education

Science/Engineering/Pharmacy degree

Job description

Amgen QA Manager Deviations role in Ireland leads a team of Quality professionals to ensure cGMP compliance, regulatory expectations and patient safety across manufacturing support. You will drive quality performance, inspection readiness, operational excellence, and continuous improvement through strong cross-functional partnership.

This position requires demonstrated leadership, expertise in deviations/investigations/CAPA/change controls, and the ability to influence across functions while