CAPA & Quality Leader — Cross-Functional GMP

MS0160 GE Healthcare Limited

Chalfont St Giles

Sur place

GBP 70 000 - 100 000

Plein temps

Il y a 5 jours

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Résumé du poste

GE HealthCare is seeking a CAPA Leader to drive timely, high-quality QMS record outcomes across sites and departments within the PDx network. You will lead CAPA/Deviation/Change Control processes, apply Lean and problem solving, and partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety and ensure regulatory compliance.

You will represent GE HealthCare during internal and external audits, participate in CAPA review boards, and coach teams to

Qualifications

Bachelor's degree from an accredited university or college.
Significant quality, manufacturing or engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).
Experience with GMP QMS and regulatory requirements.
Experience leading cross-functional teams and change initiatives.

Responsabilités

Ensures all areas of the QMS are analyzed and evaluated for input to the QMS record.
Manages execution of the QMS records using project management and lean methodologies.
Leads CAPA Review Boards with site leadership to address risks.
Owns site trending and data analysis inputs to the CAPA/Deviation/Change Control.
Supports site audits and represents GE HealthCare to external agencies.
Coaches and develops others as an individual contributor.