CAPA & Quality Leader: Cross-Functional Change & Compliance

Ge Healthcare; Chalfont St Giles; In loco; GBP 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

TWD system

Lean expertise

GMP QMS

Root-cause analysis

Cross-functional leadership

Communication skills

Project management

Formazione

Bachelor's degree

Descrizione del lavoro

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.