Country Quality Lead – Australia & New Zealand

About the role

The Country Quality Lead will oversee the implementation and maintenance of the Quality Management System for GxP‑related processes across Australia and New Zealand. Reporting to Commercial Operations, this senior position ensures that products, information and services meet regulatory standards and patient needs.

Key responsibilities

• Develop and execute a country‑wide quality program aligned with local and corporate objectives.
• Lead strategic quality initiatives, audits, and corrective actions in compliance with ISO 9001:2015, GMP, GWP, GLP and relevant TGA/MEDSAFE regulations.
• Manage product quality complaints, recall events and repackaging systems.
• Supervise third‑party manufacturing sites, reviewing master production documentation, stability and validation programs.
• Maintain document‑control systems and ensure proper product release and hold status management.
• Support product launches, transfers and technical transfers by providing quality expertise.
• Provide training on quality systems and collaborate with supply, regulatory affairs and medical teams.

Required profile

• Proven experience leading GxP quality systems in the pharmaceutical or medical device sector.
• Strong knowledge of Australian TGA and New Zealand MEDSAFE regulations.
• Demonstrated ability to build cross‑functional relationships with internal stakeholders, customers and suppliers.
• Excellent analytical and problem‑solving skills with a focus on continuous improvement.

Required skills

• ISO 9001:2015 implementation and maintenance
• Good Manufacturing Practice (GMP)
• Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• GxP regulatory knowledge (TGA, MEDSAFE)
• Audit planning and execution
• Document management systems
• Recall and complaint handling procedures