CAPA Leader, Regional Quality PDx

Ge Healthcare; Amersham; On-site; GBP 70,000 - 95,000; Full time

Job summary

GE HealthCare is seeking a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across PDx sites, using project management, Lean, and problem-solving to ensure timely, high-quality QMS outcomes. You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety and ensure regulatory compliance.

You will lead CAPA Review Boards, manage site data and trending, and guide cross-functional teams to address complex problems.

Qualifications

• Bachelor's degree from an accredited university or college.
• Strong relevant Quality, Manufacturing or Engineering experience in a regulated industry.

Responsibilities

• Lead CAPA/Deviation/Change Control record closures across sites/departments.
• Drive timely, high-quality QMS outcomes using project management and Lean methods.
• Lead CAPA Review Boards and partner with site leadership on risk mitigation.
• Own site trending and data analysis for CAPA/Deviation/Change Control inputs.
• Coach and develop others within Quality and cross-functional teams.
• Represent GE HealthCare during internal and external audits and interface with regulators.

Skills

CAPA & Deviation processes

QMS & GMP knowledge

Lean methodologies

Project management

Cross-functional collaboration

Analytics & problem solving

Regulatory compliance

Audits & regulatory interfaces

Leadership & coaching

Education

Bachelor's degree (Quality/Engineering/Manufacturing)

Job description

As a CAPA Leader, you will lead the effective closure of all CAPA/Deviation/Change Control records within specific sites/ departments across the PDx network. In this role, you 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, you 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. You will also represent GE HealthCare during internal and external audits and may interface with regulatory authorities.

• Ensuring 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.
• Managing execution of the QMS records, employing project management, problem solving, and lean methodologies to ensure robust quality decisions and timeliness.
• Leading CAPA Review Boards, partnering with site leadership to proactively address risks.
• Owning site trending and data analysis for inputs to the CAPA/Deviation/Change Control process.
• Leading others to find creative solutions to address complex problems using a variety of statistical and analysis techniques.
• Ensuring site audit readiness and supports Quality System audits, representing GE HealthCare to external agencies.
• Coaching and develops others in their organization as an individual contributor.
• Bachelor's degree from an accredited university or college.
• Strong relevant Quality, Manufacturing or Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals.

Desired Characteristics

• 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.