Regional Quality Manager (PDx) ANZ

GE HealthCare

Sydney

On-site

AUD 180,000 - 240,000

Full time

3 days ago

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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

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 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 New 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 autonomy while working within established GE HealthCare Quality policies, procedures, and operating mechanisms. The incumbent is expected to utilize technical expertise, analytical thinking, and sound judgment to solve complex quality and compliance challenges, influence stakeholders, and drive business results.

Required Qualifications

Advanced experience in Quality Assurance, Healthcare Quality, Pharmaceutical Quality, Medical Device Quality, Life Sciences, or other regulated healthcare environments.
Knowledge level comparable to a Bachelor's degree from an accredited university or college in Pharmacy, Science, Engineering, Healthcare, Quality Management, Life Sciences, or a related technical discipline (or equivalent combination of education and relevant experience).
Demonstrated knowledge of Quality Management Systems (QMS), Good Distribution Practice (GDP), risk management, CAPA, investigations, auditing, change control, training systems, supplier quality management, and regulatory compliance.
Working knowledge of pharmaceutical, radiopharmaceutical, healthcare, medical device, or regulated distribution requirements applicable to Australia and New Zealand.
Ability to interpret regulatory requirements and translate them into compliant operational processes.
Experience working within a matrix organization and collaborating effectively across multiple functions and geographies.
Strong problem‑solving, decision‑making, and risk‑based thinking capabilities.
Ability to influence stakeholders and drive compliance and quality objectives within cross‑functional teams.

Desired Characteristics

Strong understanding of GE HealthCare Quality principles, PDx Quality Management Systems, GxP requirements, Good Distribution Practice (GDP), and regulated healthcare operations.
Familiarity with Therapeutic Goods Administration (TGA) requirements, Medsafe expectations, and ANZ healthcare regulatory frameworks.
Experience interacting with regulatory authorities, inspectors, customers, and external auditors.
Demonstrated experience leading audits, inspections, supplier quality activities, and quality system improvement programs.
Strong oral and written communication skills with the ability to communicate effectively across all levels of the organization.
Demonstrated ability to analyze data, identify trends, solve complex problems, and implement sustainable corrective actions.
Established project management, change management, and continuous improvement skills.
Ability to document, plan, prioritize, market, and execute quality and compliance programs successfully.
Strong leadership presence with the ability to coach, mentor, and influence individuals and teams without direct authority.
Experience with electronic Quality Management Systems, document management systems, and digital quality tools.
Demonstrated ability to balance regulatory compliance, business objectives, operational efficiency, and customer needs.
High degree of integrity, accountability, customer focus, and commitment to patient safety and product quality.
Lead Auditor qualification or equivalent audit experience is desirable.
Experience supporting product recalls, field actions, inspections, regulatory submissions, or post‑market quality activities is preferred.

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