Senior Commercial Quality Leader - ANZPI Diagnostics

Abbott Laboratories; Sydney; On-site; AUD 150,000 - 190,000; Full time

Benefits offered by this job

Discounted Healthcare

Fitness Passport

Discounted Shares Program

Learning and development opportunities

Onsite parking and 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, based in Macquarie Park, Sydney. This leadership role ensures QMS effectiveness, regulatory compliance, and continuous improvement within the Infectious Disease business.

You will build a high-performing team, partner with Commercial, Regulatory Affairs, Supply Chain and Global Quality, and drive audits, CAPA, risk management and

Qualifications

• Bachelor's degree in Science or 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.
• Strong understanding of QMS, CAPA, risk management, audits, and regulatory compliance.

Responsibilities

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

Skills

Quality leadership

Regulatory compliance

Stakeholder influencing

Audits & CAPA

QMS knowledge

Risk management

Communication

Independence

Education

Bachelor's degree in Science or related

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, based in Macquarie Park, Sydney. This leadership role ensures QMS effectiveness, regulatory compliance, and continuous improvement within the Infectious Disease business.

You will build a high-performing team, partner with Commercial, Regulatory Affairs, Supply Chain and Global Quality, and drive audits, CAPA, risk management and