CAPA Leader

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.

Responsibilities

• 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.
• 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.
• 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.

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.

Benefits

• 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

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.