QA Manager, Deviations

Ireland \- Dun Laoghaire
JOB ID: R\-247533 LOCATION: Ireland \- Dun Laoghaire WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jun. 18, 2026 CATEGORY: Quality SALARY RANGE: 75,915\.20 EUR \- 102,708\.80 EUR
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.

• 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.

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