QA Manager, Deviations

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

Career Category Quality Job Description QA Manager Deviations Role Overview

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.

Salary Range

75,915.20 EUR - 102,708.80 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen