Regional Quality Manager (PDx) ANZ
Core
Establish, maintain, and continuously improve the Quality Management System (QMS) for Pharmaceutical Diagnostics across Australia and New Zealand, ensuring regulatory compliance and patient safety.
Role type
Senior Quality Manager (Pharmaceutical Diagnostics)
Builds
Pharmaceutical Diagnostics quality systems and compliance frameworks
Domain
Healthcare / Pharmaceutical Diagnostics / Regulated Distribution
Required skills
Quality Management Systems (QMS), Good Distribution Practice (GDP), risk management, CAPA, investigations, auditing, change control, supplier quality management, regulatory compliance, problem-solving, stakeholder influence
Preferred skills
GxP requirements, TGA/Medsafe regulatory frameworks, audit leadership, project management, continuous improvement, data analysis, electronic QMS tools
Technologies
Electronic Quality Management Systems, document management systems
Responsibilities
Lead regulatory inspection readiness and represent the company during audits; Manage quality events, investigations, CAPA, and change controls; Oversee supplier and third-party logistics provider qualification and monitoring; Partner with cross-functional teams to ensure compliant business operations; Analyze quality performance indicators to drive continuous improvement.
Seniority
Senior, hands-on IC with leadership responsibilities