Commercial Quality Manager ANZPI

About the role

Abbott's Rapid Diagnostics division is seeking an experienced Commercial Quality Manager for its Infectious Disease business, covering Australia, New Zealand and the Pacific Islands. Based in Macquarie Park, Sydney, the role reports to the Head of Commercial Quality and ensures the effectiveness and compliance of the Quality Management System (QMS), leads audit and regulatory activities, drives continuous improvement and builds a high-performing Commercial Quality team.

Key responsibilities

• Lead and maintain the QMS in line with standards, regulations and Abbott Quality requirements
• Promote quality awareness and compliance across the ANZPI organisation
• Manage internal, supplier and external audit programmes, including preparation, responses and follow-up
• Act as key contact for regulatory authorities and ensure compliant communication across the region
• Lead post-market quality activities such as product recalls, advisory notices and product holds
• Drive CAPA, quality improvement and compliance activities
• Develop and maintain Quality Agreements with suppliers and business partners
• Monitor and report quality metrics, compliance performance and management review activities
• Provide quality guidance, training and support to internal stakeholders
• Lead, coach and mentor the Commercial Quality team

Required profile

• Bachelor's degree in Science or a related discipline
• Minimum 5 years' experience in Quality Assurance or a closely related field
• Experience in medical device, diagnostics, pharmaceutical or other highly regulated industries
• Team leadership and people management experience
• Quality auditing certification

Required skills

• Strong understanding of QMS, CAPA, risk management, audits and regulatory compliance
• Excellent communication, stakeholder management and influencing skills
• Attention to detail, integrity and professionalism

What we offer

• Discounted healthcare
• Fitness Passport access
• Discounted shares program
• Learning and development opportunities
• Onsite parking and a barista