Senior Commercial Quality Leader, ANZPI Diagnostics

Abbott; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Discounted Healthcare

Access to Fitness Passport

Discounted Shares Program

Learning and development opportunities

Onsite parking and a barista

Job summary

Abbott is seeking an experienced Commercial Quality Manager - ANZPI to lead the Commercial Quality function across Australia, New Zealand and the Pacific Islands within our Infectious Disease business, based in Macquarie Park, Sydney.

This role reports to the Head of Commercial Quality and ensures the effectiveness and compliance of the Quality Management System, audits, CAPA and continuous improvement across the region.

Qualifications

• Bachelor's degree in Science or related discipline.
• Minimum 5 years' experience in Quality Assurance or a closely related field.
• Experience within the medical device, diagnostics, pharmaceutical, or other highly regulated industries.
• Quality auditing certification.
• Strong understanding of QMS, CAPA, risk management, audits, and regulatory compliance requirements.
• Excellent communication, stakeholder management, and influencing skills.
• High attention to detail, integrity, professionalism, and the ability to work independently.

Responsibilities

• Lead and maintain the QMS in compliance with standards, regulations, and Abbott Quality requirements.
• Promote quality awareness and compliance across the ANZPI organisation.
• Manage internal, supplier, and external audit programs, including audit prep, responses and follow-up.
• Act as a key contact for regulatory authorities and ensure compliant communication across the region.
• Lead post-market quality activities including recalls, advisory notices, and product holds.
• Drive CAPA, Quality Improvement (QI), and compliance activities to ensure timely resolution of quality issues.
• Develop and maintain Quality Agreements with suppliers and business partners.
• Monitor and report on quality metrics, compliance performance, and management reviews.
• Provide quality guidance, training, and support to internal stakeholders.
• Lead, coach, mentor, and develop a high-performing Commercial Quality team.

Skills

Quality leadership

Regulatory knowledge

Stakeholder management

Audit management

Team leadership

Education

Bachelor's degree in Science

Job description

Abbott is seeking an experienced Commercial Quality Manager - ANZPI to lead the Commercial Quality function across Australia, New Zealand and the Pacific Islands within our Infectious Disease business, based in Macquarie Park, Sydney.

This role reports to the Head of Commercial Quality and ensures the effectiveness and compliance of the Quality Management System, audits, CAPA and continuous improvement across the region.