CAPA Leader

GE HealthCare; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

GE HealthCare seeks an experienced Quality leader to strengthen CAPA, deviations, change control, investigations and escalation across the product lifecycle. This role provides independent governance and drives sustainable improvement with data-driven insights.

As CAPA Lead, you will develop and execute CAPA programs, lead quality events, drive root cause analysis, monitor effectiveness and partner with senior leaders to ensure timely, robust issue resolution and regulatory readiness.

Qualifications

• Strong knowledge of CAPA, deviation management, investigations, change control and Quality Management Systems.
• Demonstrated governance and independent oversight across complex, cross-functional processes.
• Analytical with quality metrics and trending to identify risk and drive improvement.
• Ability to influence senior stakeholders and drive continuous improvement.

Responsibilities

• Own and strengthen CAPA, deviations, change control, investigations, quality issue management and escalation.
• Drive investigation excellence, including root cause analysis, CAPA effectiveness and recurrence prevention.
• Provide independent monitoring and oversight of end-to-end process performance.
• Develop meaningful KPIs, trending and management insights for proactive quality risk escalation.
• Lead continuous improvement initiatives in partnership with key functions.
• Ensure significant quality and compliance issues are evaluated, escalated, investigated and resolved.
• Partner with senior leaders to maintain visibility of Quality Management System performance and risks.
• Support inspection readiness and regulatory or internal audit activities related to CAPA and deviations.
• Promote quality accountability and a proactive quality culture across boundaries.
• Participate in industry forums to bring external best practice into the organisation.

Skills

CAPA

Deviation management

Investigations

Change control

Quality Management Systems

Root cause analysis

KPIs & trending

Stakeholder collaboration

Continuous improvement

GxP/regulatory knowledge

Job description

Job Description Summary

We are looking for an experienced quality leader to strengthen how CAPA, deviations, change control, investigations and quality escalation and governed

This is a highly visible role with the opportunity to influence Quality Management System performance across functions, strengthen investigation excellence and drive sustainable continuous improvement throughout the product lifecycle.

As CAPA Lead, you will develop and execute CAPA, quality events, deviation management, change control, investigation excellence and escalation. You will provide independent oversight of process health, identify emerging risks and trends, and work with senior leaders and functional partners to ensure issues are addressed effectively and sustainably.

Job Description

Responsibilities

• Own and strengthen the process for CAPA, deviations, change control, investigations, quality issue management and escalation.
• Drive investigation excellence, including stronger root cause analysis, CAPA effectiveness and recurrence prevention.
• Provide independent monitoring and oversight of end-to-end process performance and remediation effectiveness.
• Develop meaningful KPIs, trending and management insights that enable proactive identification and escalation of quality risks.
• Lead and champion continuous improvement initiatives in partnership with key functions.
• Ensure significant quality and compliance issues are appropriately evaluated, escalated, investigated and resolved.
• Partner with senior leaders to maintain visibility of Quality Management System performance, compliance status and key risks.
• Support inspection readiness and regulatory or internal audit activities related to CAPA, deviations, investigations, change control and escalation.
• Promote quality accountability and a proactive quality culture across organisational and functional boundaries.
• Participate in relevant industry forums and benchmarking initiatives to bring external best practice into the organisation.

Qualifications and Requirements

• Strong experience in pharmaceutical, radiopharmaceutical or another highly regulated GxP environment.
• Deep knowledge of CAPA, deviation management, investigations, change control and Quality Management Systems.
• Demonstrated ability to provide governance and independent oversight across complex, cross-functional processes.
• Strong analytical capability, including the use of quality metrics and trending to identify risk and drive improvement.
• Ability to influence and collaborate effectively with senior stakeholders across functional and organisational boundaries.
• A continuous improvement mindset with the ability to translate quality strategy into sustainable process improvements.
• Strong communication, coaching and change leadership capabilities.

Why This Role Matters

This role sits at the intersection of compliance, quality performance and continuous improvement. The CAPA Lead will help ensure that quality issues do more than close on time: they are understood, addressed at root cause, escalated appropriately and used to drive learning and sustained improvement across the organisation.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, g ender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No