Regional Quality Leader ANZPI (Diagnostics)

Thornton Tomasetti; Sydney; On-site; AUD 130,000 - 170,000; Full time

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 from Macquarie Park, Sydney. You will oversee QMS compliance, audits, CAPA, and regulatory communications, while developing a high‑performing team.

The role partners with Commercial, Regulatory Affairs, Supply Chain, Operations, and Global Quality to drive quality excellence and improve patient outcomes in a regulated environment.

Qualifications

• Bachelor's degree in Science or related discipline.
• 5+ years' experience in Quality Assurance or a closely related field.
• Experience within 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 Quality Management System (QMS) in compliance with applicable standards, regulations, and Abbott Quality requirements.
• Promote quality awareness and compliance across the ANZPI organisation.
• Manage internal, supplier, and external audit programs, including audit preparation, responses, and follow-up activities.
• Act as a key contact for regulatory authorities and ensure compliant communication across the region.
• Lead post-market quality activities including product recalls, advisory notices, and product holds.
• Drive CAPA, Quality Improvement (QI), and compliance activities to ensure timely and effective resolution of quality issues.
• Develop and maintain Quality Agreements with suppliers and business partners.
• Monitor and report on quality metrics, compliance performance, and management review activities.
• Provide quality guidance, training, and support to internal stakeholders.
• Lead, coach, mentor, and develop a high-performing Commercial Quality team while establishing clear accountability and performance expectations.

Skills

Leadership

Audit & compliance

Communication

Regulatory understanding

Education

Bachelor's degree in Science or related discipline

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 from Macquarie Park, Sydney. You will oversee QMS compliance, audits, CAPA, and regulatory communications, while developing a high‑performing team.

The role partners with Commercial, Regulatory Affairs, Supply Chain, Operations, and Global Quality to drive quality excellence and improve patient outcomes in a regulated environment.