Country Quality Lead Australia & New Zealand

About The Role

We are seeking a dedicated Country Quality Lead for Australia & New Zealand based in Barangaroo, Sydney. This full-time position is responsible for overseeing and maintaining the country's Quality system across Good Practice (GxP) transversal processes and new product introductions, engaging all relevant departments involved in health-regulated activities. The role ensures the availability of safe, effective, and compliant products and services that fulfill patient and customer requirements.

Primary Duties

• Lead and develop the quality program aligned with both corporate and local strategic goals within commercial operations.
• Drive strategic quality initiatives and instill a culture of quality throughout the business.
• Build and maintain effective collaborations with internal teams, external customers, and suppliers.
• Implement monitoring systems to assess the overall health of the Quality System continuously.
• Possess and apply in-depth knowledge of TGA and MEDSAFE GxP regulations, guiding teams on relevant projects.
• Ensure organizational quality system compliance with ISO9001:2015 standards.
• Oversee and manage product quality complaint procedures compliant with local and company policies.
• Plan and execute audits to detect and correct quality discrepancies in line with GMP, GWP, GLP, ISO, and company protocols.
• Supervise third-party manufacturing sites to mitigate non-conformity risks, including reviewing master production files, stability, and validation documentation.
• Authorize product release matching registered specifications and manage hold statuses appropriately.
• Maintain an efficient document control system and collaborate on documentation development.
• Lead responses to critical quality issues such as product recalls.
• Apply quality management tools to enhance company processes and engage with customers and suppliers to refine operations.
• Participate in continuous professional development through conferences, associations, and quality networks.
• Manage repackaging systems for products distributed in Australia and New Zealand.
• Support internal departments such as Supply, Regulatory Affairs, and Medical in manufacturing and quality matters.
• Assist product launches and transfers by acquiring technical product and process knowledge and coordinating the technical transfer packages.
• Deliver training on quality systems when required and provide assistance across the Quality team functions.
• Engage in local and global project activities as necessary.
• Recruit, mentor, and coach team members to achieve high performance standards.
• Conduct regular performance and career development reviews following the Sanofi Performance Management Process.
• Manage teams to meet project timelines and budget expectations.
• Support Multi-Country Organization (MCO) initiatives, particularly with South Korea and Australia New Zealand regions, as a subject matter expert.
• Promote quality best practices and encourage knowledge sharing among quality teams.

Candidate Profile

Essential Qualifications and Experience:

• A minimum of 5 to 10 years' experience in a pharmaceutical quality role.
• Understanding of medical terminology and product knowledge within pharmaceuticals.
• Comprehensive knowledge of GxP codes and manufacturing and warehousing operations.
• Familiarity with quality systems and document management processes.
• Tertiary education in life sciences or a related discipline.

Preferred Skills and Expertise:

• Strong presentation and negotiation abilities.
• Experience in team leadership and people management.
• Proficiency with SAP and digital quality management systems such as VEEVA.
• Registration with relevant professional associations or government regulatory boards.