Regional Quality Manager (PDx) ANZ

About the role

The Regional Quality Manager (PDx) ANZ leads the quality management system for GE HealthCare Pharmaceutical Diagnostics across Australia and New Zealand, ensuring compliance with global policies, local regulations and customer expectations.

Key responsibilities

• Provide leadership and oversight of the ANZ PDx Quality Management System, aligning with global requirements and local regulatory obligations.
• Drive quality culture through objectives, metrics, management review processes and continuous improvement initiatives.
• Represent GE HealthCare during regulatory inspections, audits and authority communications.
• Manage quality systems including events, investigations, CAPA, change controls, risk management, training, documentation, supplier quality and audit processes.
• Ensure Good Distribution Practice (GDP) compliance across warehousing, transportation and third‑party logistics.
• Support product disposition, recalls, field actions and business continuity activities for the ANZ market.
• Lead internal, supplier and regional audits, ensuring effective remediation of findings.
• Partner with Regulatory Affairs, Supply Chain, Customer Service and Global Quality to manage risk and compliance.

Required profile

• Advanced experience in Quality Assurance, Healthcare, Pharmaceutical or Medical Device regulated environments.
• Knowledge comparable to a Bachelor’s degree in Pharmacy, Science, Engineering, Healthcare or related discipline.
• Strong understanding of QMS, GDP, risk management, CAPA, auditing and regulatory compliance in Australia and New Zealand.
• Ability to work autonomously within matrix organisations and influence cross‑functional teams.

Required skills

• Quality Management Systems (QMS)
• Good Distribution Practice (GDP)
• CAPA management
• Auditing and inspection readiness
• Change control processes
• Risk management
• Regulatory compliance (TGA, Medsafe)
• Supplier quality management
• Electronic Quality Management Systems