Job Description Summary

The Regional Quality Manager (PDx) ANZ is responsible for establishing, maintaining, and continuously improving the GE HealthCare Pharmaceutical Diagnostics (PDx) Quality Management System (QMS) across Australia and New Zealand. The role serves as the designated Quality leader for the ANZ region, ensuring compliance with applicable GE HealthCare Quality policies, PDx global procedures, local regulatory requirements, Good Distribution Practices (GDP), and customer expectations.

The Regional Quality Manager (PDx) ANZ is responsible for establishing, maintaining, and continuously improving the GE HealthCare Pharmaceutical Diagnostics (PDx) Quality Management System (QMS) across Australia and New Zealand. The role serves as the designated Quality leader for the ANZ region, ensuring compliance with applicable GE HealthCare Quality policies, PDx global procedures, local regulatory requirements, Good Distribution Practices (GDP), and customer expectations.

The Regional Quality Manager drives a culture of quality and compliance through effective oversight of quality systems, regulatory inspections, supplier and service provider management, audits, quality events, CAPA, change control, training, and management review activities. The role partners with commercial, customer service, logistics, supply chain, regulatory affairs, and global quality teams to ensure product quality, patient safety, and business continuity across the ANZ region.

Job Description

Roles and Responsibilities

- Provide leadership and oversight of the ANZ PDx Quality Management System, ensuring alignment with global PDx requirements and local regulatory obligations.
- Drive quality culture and compliance through the establishment of effective quality objectives, metrics,



management review processes, reporting mechanisms, and continuous improvement initiatives.
- Serve as the designated Quality representative for Pharmaceutical Diagnostics operations in Australia and New Zealand and act as the primary quality contact for internal and external stakeholders.
- Ensure ongoing compliance with applicable requirements of the Therapeutic Goods Administration (TGA), Medsafe, applicable GDP requirements, and other relevant regulatory authorities.
- Lead regulatory inspection readiness activities and represent GE HealthCare during inspections, audits, regulatory inquiries, and authority communications.
- Ensure effective management of quality systems including Quality Events, Investigations, Corrective and Preventive Actions (CAPA), Change Controls, Risk Management, Training, Documentation, Supplier Quality, and Audit Management processes.
- Provide quality oversight and approval within established authority levels for quality records, investigations, risk assessments, CAPAs, deviations, and change controls.
- Ensure timely investigation, escalation, and resolution of quality and compliance issues, utilizing risk-based decision-making principles.
- Act as Quality lead for Good Distribution Practice (GDP) compliance across Australia and Recent Zealand, ensuring effective oversight of customer service, warehousing, transportation,



distribution activities, and third-party logistics providers.
- Ensure distributors, service providers, contract partners, and other GDP‑relevant third parties are appropriately qualified, monitored, and managed in accordance with company and regulatory requirements.
- Support product disposition decisions, product holds, recalls, field actions, complaints, market actions, and business continuity activities impacting the ANZ market.
- Lead and support internal audits, supplier audits, self‑inspections, and regional quality assessments while ensuring effective remediation and closure of identified findings.
- Maintain inspection and audit readiness by ensuring quality systems, records, and personnel remain compliant and prepared for regulatory review.
- Partner closely with Regulatory Affairs, Supply Chain, Customer Service, Commercial Operations, Pharmacovigilance, and Global Quality functions to ensure compliant business operations and effective risk management.
- Monitor and analyze quality performance indicators, audit trends, compliance risks, customer feedback, CAPA effectiveness, and other quality metrics to identify improvement opportunities.
- Provide quality leadership, coaching, mentoring, and technical guidance to colleagues and cross‑functional teams while influencing decisions through expertise and collaboration.
- Lead or participate in regional and global quality projects, process improvement initiatives, and quality transformation activities.
- Act as an escalation point for significant quality, regulatory, patient safety, or business continuity risks impacting the ANZ region.
- The role requires the ability to operate with a degree of autonom

📌 Regional Quality Manager (Sydney)
🏢 GE Healthcare
📍 Sydney