QA Deviations Lead – Quality, Compliance & Improvement

Amgen; Dublin; On-site; EUR 120,000 - 150,000; Full time

Job summary

Amgen Ireland invites applications for a QA Manager Deviations to lead a team of quality professionals, ensure cGMP compliance, and drive continuous improvement across manufacturing support functions. The role focuses on deviations, CAPAs, change control, and audit readiness, safeguarding patient safety and product quality.

You will partner with Manufacturing, Engineering, Validation, and Quality Control, provide risk-based decisions, and guide inspections, governance forums, and regulatory

Qualifications

• Degree in Science, Engineering, Pharmacy, or related discipline.
• 7+ years of experience in pharmaceutical/biotech with increasing responsibility.
• Strong GMP quality systems knowledge including deviations, investigations, CAPA, change controls and risk management.
• Experience supporting regulatory inspections and audit readiness.

Responsibilities

• Lead and develop a high-performing team of Quality professionals in deviations, investigations, and CAPAs.
• Provide strategic and operational leadership for manufacturing deviations, ensuring cGMP compliance.
• Oversee quality management processes including deviations, investigations, CAPAs, change controls, and quality assessments.
• Provide risk-based decision-making for complex quality and regulatory issues, escalating risks as needed.
• Partner cross-functionally with Manufacturing, Engineering, Validation, Quality Control and Supply Chain to support compliant operations.
• Lead inspection readiness activities and represent QA during audits and governance forums.

Skills

Leadership

GMP quality systems

Cross-functional collaboration

Regulatory inspections

Communication skills

Education

Degree in Science/Engineering/Pharmacy

Job description

Amgen Ireland invites applications for a QA Manager Deviations to lead a team of quality professionals, ensure cGMP compliance, and drive continuous improvement across manufacturing support functions. The role focuses on deviations, CAPAs, change control, and audit readiness, safeguarding patient safety and product quality.

You will partner with Manufacturing, Engineering, Validation, and Quality Control, provide risk-based decisions, and guide inspections, governance forums, and regulatory