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About the Role
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 role 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.
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.
Requirements
- 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.
Skills
- Quality Management Systems (QMS)
- Good Distribution Practice (GDP)
- Risk management
- CAPA
- Investigations
- Auditing
- Change control
- Training systems
- Supplier quality management
- Regulatory compliance
- Therapeutic Goods Administration (TGA) requirements
- Medsafe expectations
- Project management
- Change management
- Continuous improvement
- Electronic Quality Management Systems
- Document management systems
- Digital quality tools
Location
- Australia
- New Zealand
Work Type
- Full-time
Experience Level
- Advanced experience
Education Level
- Bachelor's degree or equivalent combination of education and relevant experience
Benefits
- Competitive salary package
- 5 weeks leave (ask about “Take 5”)
- Flexible working options
- Career development locally and globally
- Employee benefits program with discounts on travel, entertainment & more
About the Company
- We offer more than just a job—we offer a career with purpose, flexibility, and global opportunity!