Commercial Quality Manager

Abbott; Sydney; On-site; AUD 120,000 - 160,000; 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 seeks an experienced Commercial Quality Manager - ANZPI to lead the QMS across Australia, New Zealand and the Pacific Islands from Macquarie Park, Sydney. You will drive audit programs, regulatory interactions, and post-market quality activities to safeguard patient outcomes.

You will develop a high-performing Commercial Quality team and partner with Commercial, Regulatory Affairs, Supply Chain and Global Quality to maintain rigorous quality standards and continuous improvement.

Qualifications

• Bachelor's degree in Science or related field.
• Minimum 5 years of experience in Quality Assurance.
• Experience in medical device, diagnostics, pharmaceutical, or other highly regulated industries.
• Demonstrated team leadership and people management experience.
• Quality auditing certification.
• Strong understanding of QMS, CAPA, risk management, audits and regulatory requirements.

Responsibilities

• Lead and maintain the QMS in compliance with standards, regulations and Abbott requirements.
• Promote quality awareness and compliance across the ANZPI organisation.
• Manage internal, supplier and external audit programs with preparation and follow-up.
• Act as a regulatory contact for authorities and ensure compliant communication.
• Lead post-market quality activities including recalls and advisory notices.
• Drive CAPA, quality improvement and compliance activities for timely resolution of issues.
• Develop and maintain Quality Agreements with suppliers and partners.
• Monitor quality metrics and management review activities.

Skills

Quality Assurance

Leadership

Auditing

QMS

Regulatory Compliance

CAPA

Stakeholder Management

Education

Bachelor's degree in Science

Job description

We are seeking an experienced and passionate 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. Reporting to the Head of Commercial Quality, this role is responsible for ensuring the effectiveness and compliance of the Quality Management System (QMS), leading audit and regulatory activities, driving continuous improvement initiatives, and developing a high-performing Commercial Quality team. This is a critical leadership role that offers the opportunity to make a significant impact on quality performance, regulatory compliance, business operations, and patient outcomes. You will partner closely with Commercial, Regulatory Affairs, Supply Chain, Operations, and Global Quality teams while fostering a culture of quality excellence and continuous improvement.

Key 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.

About you

• 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.
• Team leadership and people management experience.
• 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.
• Discounted Healthcare
• Access to Fitness Passport
• Discounted Shares Program
• Learning and development opportunities
• Onsite parking and a barista

About us

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Our Rapid Diagnostics division is committed to delivering innovative diagnostic solutions that help healthcare professionals make informed decisions quickly and confidently.