QA Manager, Deviations

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

QA Manager Deviations

The QA Manager (Deviations) is a key leadership role responsible for overseeing critical quality systems and providing quality guidance across manufacturing support functions. Leading a team of Quality professionals, this position ensures compliance with GMP requirements, regulatory expectations, and internal standards while driving quality performance, inspection readiness, operational excellence, and patient safety. Through effective cross-functional partnership, the role fosters a culture of quality, accountability, compliance, and continuous improvement across the site.

Key Responsibilities

• Lead and develop a high-performing team of Quality professionals through recruitment, selection, training and development to foster a culture of safety, quality, accountability, inclusion, and continuous improvement.
• Provide strategic and operational leadership for manufacturing deviations, ensuring compliance with cGMP, GDP, Amgen standards, and global regulatory requirements.
• Oversee the effective execution of Quality Management System processes, including deviations, investigations, CAPAs, change controls, and associated quality assessments.
• Provide quality leadership and risk-based decision-making for complex quality, compliance and operational issues, escalating significant risks as appropriate.
• Partner cross-functionally with Manufacturing, Engineering, Validation, Quality Control, Supply Chain, and other stakeholders to support compliant and reliable operations.
• Lead inspection readiness activities and represent Quality Assurance during audits, inspections, and governance forums, ensuring effective management of observations, commitments, and remediation activities.
• Monitor quality system performance and trends to identify risks, drive continuous improvement, and enhance operational effectiveness.
• Support implementation of site and global quality strategies, driving simplification, standardization, and optimization of quality processes and systems.
• Promote compliance with environmental, health, safety, and sustainability requirements while fostering a safe and compliant workplace.

Preferred Qualifications

• Degree in Science, Engineering, Pharmacy, or related discipline.
• Demonstrated leadership experience managing teams, developing talent and improving performance.
• 7+ years of experience in the pharmaceutical or biotechnology industry, with progressively increasing responsibility.
• Strong expertise in GMP quality systems, including deviations, investigations, CAPA management, change controls and risk management.
• Experience supporting regulatory inspections and leading audit readiness activities.
• Proven ability to influence and collaborate effectively across functions and organizational levels in a matrix environment.
• Excellent communication, stakeholder management, facilitation, and decision-making skills.
• Strong analytical, problem-solving, and critical-thinking skills, with a focus on continuous improvement and operational excellence.