ANZ Regional Quality Leader, PDx

MS0229 GE Healthcare AS; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

5 weeks leave

Flexible options

Job summary

GE HealthCare in Australia and New Zealand seeks a Regional Quality Manager to establish, maintain, and continually improve the PDx QMS across the ANZ region, ensuring compliance with GDP, local regulatory requirements, and customer expectations.

You will lead regulatory inspections, CAPA, change control, supplier quality, and audits, partnering with Regulatory Affairs, Supply Chain, and cross‑functional teams to safeguard patient safety and business continuity in ANZ.

Qualifications

• Advanced experience in Quality Assurance in healthcare environments.
• Bachelor-level degree in Pharmacy, Science, Engineering, or related field.
• Knowledge of GDP, CAPA, investigations, audits, change control, training systems, supplier quality management, and regulatory compliance.

Responsibilities

• Lead ANZ PDx Quality Management System and ensure alignment with global PDx requirements and local regulatory obligations.
• Drive quality culture and compliance through effective quality objectives, metrics, management review processes, reporting mechanisms, and continuous improvement initiatives.
• Act as designated Quality representative for Pharmaceutical Diagnostics operations in Australia and New Zealand and be the primary quality contact for internal and external stakeholders.
• Ensure ongoing compliance with TGA, Medsafe, GDP, and other regulatory requirements; oversee audits, inspections, and regulatory inquiries.

Skills

Quality Assurance

Regulatory compliance

Audits

Leadership

Education

Bachelor's degree in Pharmacy or related field

Tools

QMS software

Job description

GE HealthCare in Australia and New Zealand seeks a Regional Quality Manager to establish, maintain, and continually improve the PDx QMS across the ANZ region, ensuring compliance with GDP, local regulatory requirements, and customer expectations.

You will lead regulatory inspections, CAPA, change control, supplier quality, and audits, partnering with Regulatory Affairs, Supply Chain, and cross‑functional teams to safeguard patient safety and business continuity in ANZ.