Commercial Quality Manager ANZPI

Abbott

Sydney

On-site

AUD 180,000 - 240,000

Full time

2 days ago

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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 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.

The Role

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.

What We're Looking For

You are a quality and compliance leader who combines strong technical expertise with the ability to influence stakeholders and drive organisational excellence. You thrive in regulated environments, enjoy solving complex quality challenges, and have a track record of building high-performing teams while maintaining the highest standards of compliance.

In addition, you will have:

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.

This is an opportunity to join a collaborative and purpose-driven organisation where quality excellence is valued and recognised. You will work alongside experienced professionals in an environment that promotes continuous learning, leadership development, and operational excellence.

We also provide some fantastic benefits for our employees such as:

Discounted Healthcare
Access to Fitness Passport
Discounted Shares Program
Learning and development opportunities
Onsite parking and a barista

The base pay for this position is

N/A

JOB DESCRIPTION:

About Abbott

The Role

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.

What We're Looking For

You are a quality and compliance leader who combines strong technical expertise with the ability to influence stakeholders and drive organisational excellence. You thrive in regulated environments, enjoy solving complex quality challenges, and have a track record of building high‑performing teams while maintaining the highest standards of compliance.

In addition, you will have:

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.

This is an opportunity to join a collaborative and purpose-driven organisation where quality excellence is valued and recognised. You will work alongside experienced professional in an environment that promotes continuous learning, leadership development, and operational excellence.

We also provide some fantastic benefits for our employees such as: