CAPA Leader

Ge Healthcare; Chalfont St Giles; On-site; GBP 90,000 - 140,000; Full time

Job summary

GE HealthCare is seeking a CAPA Leader to drive closure of CAPA, Deviation and Change Control records across sites, applying Lean tools and robust problem-solving methods to protect patient safety and regulatory compliance.

You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to analyze metrics, lead reviews, and ensure timely, high-quality decisions within a GMP framework. Strong leadership and communication are essential.

Qualifications

• Bachelor's degree from an accredited university or college.
• Significant QA, Manufacturing or Engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).

Responsibilities

• Lead CAPA/Deviation/Change Control records closure across sites/departments.
• Manage QMS record execution using project management and lean methods.
• Lead CAPA Review Boards with site leadership.
• Own site trending and data for CAPA/Deviation/Change inputs.
• Coach and develop others; interface with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs.
• Ensure site audit readiness and represent GE HealthCare during audits.
• Collaborate to address risk and implement effective solutions.

Skills

TWD system

Lean expertise

GMP QMS

Root-cause analysis

Cross-functional leadership

Communication skills

Project management

Education

Bachelor's degree

Job description

In this role, the CAPA Leader will lead the effective closure of all CAPA/Deviation/Change Control records within specific sites/ departments across the PDx network. The CAPA Leader will drive timely, high-quality QMS record outcomes through strong project management, Lean methodologies, structured problem solving, and cross-functional collaboration. As a key member of the Quality organisation, they will partner with stakeholders within Quality as well as Supply Chain, Operations, Engineering and Regulatory Affairs, to apply problem solving tools to protect patient safety, strengthen quality systems, improve product quality, and ensure regulatory compliance. They will represent GE HealthCare during internal and external audits and may interface with regulatory authorities.,

• Ensures all areas of the QMS are analyzed and evaluated for input to the QMS record, problems are escalated and documented appropriately, and regulatory requirements are met.
• Manages execution of the QMS records, employing project management, problem solving, and lean methodologies to ensure robust quality decisions and timeliness.
• Leads CAPA Review Boards, partnering with site leadership to proactively address risks.
• Owns site trending and data analysis for inputs to the CAPA/Deviation/Change Control process.
• Leads others to find creative solutions to address complex problems using a variety of statistical and analysis techniques.
• Ensures site audit readiness and supports Quality System audits, representing GE HealthCare to external agencies.
• Coaches and develops others in their organization as an individual contributor.
  Bachelor's degree from an accredited university or college
• Significant Quality, Manufacturing or Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals

Desired Skills

• Experienced user of the TWD system and the QA procedures governing Quality Events
• Established project management skills and Lean expertise. Ability to lead cross-functional teams to plan and execute projects on time.
• Demonstrated understanding of a GMP QMS and regulatory requirements
• Exceptional analytical, problem solving & root-cause analysis skills
• Ability to effectively manage execution of tasks with competing priorities.
• Excellent communication skills - presentation, verbal and written to all organizational levels.
• Demonstrated collaboration and conflict resolution skills. Experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
• Experience leading and implementing change
• Strong interpersonal and leadership skills.
  GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.