ANZPI Commercial Quality Leader: QMS & Compliance

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

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.