CAPA Leader

MS0234 GE Healthcare Ireland Limited; Cork; On-site; EUR 120,000 - 150,000; Full time

Job summary

GE HealthCare Ireland Limited is seeking an experienced CAPA Lead to strengthen CAPA, deviations, change control, investigations, and escalation across the quality management system. You will provide independent oversight of process health, identify risks and drive sustainable improvement throughout the product lifecycle.

You will develop and execute CAPA programs, lead quality events, and partner with senior leaders to ensure issues are addressed effectively and prevent recurrence.

Qualifications

• Experience in GxP regulated environments.
• Deep knowledge of CAPA, deviation management, investigations, change control.

Responsibilities

• Own and strengthen the process for CAPA, deviations, change control, investigations and escalation.
• Drive investigation excellence, including root cause analysis and recurrence prevention.
• Provide monitoring and oversight of end-to-end process performance and remediation effectiveness.
• Develop KPIs, trends and insights to proactively identify quality risks.
• Lead continuous improvement initiatives with key functions.
• Support inspection readiness and audits related to CAPA, deviations, investigations, change control and escalation.

Skills

CAPA governance

Root cause analysis

Change management

Quality metrics

Stakeholder influence

Tools

QMS (Quality Management System)

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.

#LI-BG1 #LI-onsite Additional Information

• Relocation Assistance Provided: No

At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.