Regional Quality Manager (PDx) ANZ

GE HealthCare · Mascot, Australia

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Role summary

GE HealthCare seeks a Regional Quality Manager to lead the Pharmaceutical Diagnostics Quality Management System across Australia and New Zealand. The role ensures compliance with regulatory requirements, drives quality culture, and manages quality systems including audits, investigations, and corrective actions.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Phenom, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

Advanced experience in Quality Assurance or pharmaceutical/medical device quality environments
Bachelor's degree in Pharmacy, Science, Engineering, or related technical discipline
Demonstrated expertise in Quality Management Systems, GDP, CAPA, and investigations
Knowledge of risk management, auditing, change control, and supplier quality processes
Working knowledge of pharmaceutical regulatory frameworks and compliance systems
Experience with regulatory inspection readiness and authority communications

What you'll be doing

Establish and maintain the ANZ PDx Quality Management System aligned with global requirements and local regulations
Lead regulatory inspection readiness and represent GE HealthCare during audits and regulatory inquiries
Oversee quality events, investigations, CAPAs, change controls, and supplier quality management
Ensure Good Distribution Practice compliance across distribution, warehousing, and third-party logistics
Monitor quality performance metrics, audit trends, and lead continuous improvement initiatives

Privacy & handoff

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