ANZ Regional Quality Leader, Pharmaceutical Diagnostics

GE HealthCare; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

5 weeks leave

Flexible working options

Career development locally and Glob

Job summary

GE HealthCare ANZ seeks a Regional Quality Manager to lead the PDx QMS across Australia and New Zealand, ensuring GDP compliance and regulatory alignment. You will partner with cross‑functional teams to safeguard product quality and patient safety.

Responsibilities include audits, CAPA, change control, and continuous improvement, with leadership across multiple regions and functions to sustain business continuity.

Qualifications

• Advanced experience in Quality Assurance or regulated healthcare environments.
• Knowledge of GDP, CAPA, investigations, and regulatory compliance.
• Ability to translate regulatory requirements into compliant processes.
• Experience in matrix organizations across multiple functions.

Responsibilities

• Provide leadership and oversee the PDx QMS across AU and NZ.
• Drive quality culture, metrics, and management review processes.
• Serve as Quality lead for GDP compliance and regulatory inspections.
• Manage quality systems including CAPA, change control, and training.
• Coordinate audits, supplier quality, and quality events.
• Support product disposition decisions, recalls, and field actions.
• Collaborate with Regulatory Affairs, Supply Chain, and Global Quality.

Skills

Quality Assurance

GDP Knowledge

Regulatory Compliance

Risk Management

Quality Audits

Leadership

Education

Bachelor's degree in Pharmacy/Science/Engineering

Tools

QMS software

Audit tools

Job description

GE HealthCare ANZ seeks a Regional Quality Manager to lead the PDx QMS across Australia and New Zealand, ensuring GDP compliance and regulatory alignment. You will partner with cross‑functional teams to safeguard product quality and patient safety.

Responsibilities include audits, CAPA, change control, and continuous improvement, with leadership across multiple regions and functions to sustain business continuity.