Quality Manager

Audax Biosciences Pty Ltd; City of Melbourne; On-site; AUD 120,000 - 150,000; Full time

Job summary

Audax Biosciences Pty Ltd in Melbourne is seeking a passionate Quality Manager to oversee quality systems across discovery and development programs.

Based at the Alfred Hospital Precinct, the role reports to the COO and drives documentation, vendor qualification, audits and data integrity to support clinical development.

You will build a fit-for-purpose QMS, maintain robust records, ensure compliance with ICH/GxP, and lead internal audits while coaching scientists in good documentation practice.

Qualifications

• Degree in science with at least four years in quality roles supporting lab research or biopharma.
• Experience building/refining QMS in a small or growing organisation.
• Working knowledge of ICH guidelines and GxP in biotech product development.

Responsibilities

• Oversee the Quality Management System, including document control and quality records.
• Develop risk-based quality systems with stage-appropriate controls.
• Own training records and coach scientists in good documentation practice.
• Qualify and monitor external providers through quality agreements and audits.
• Build quality framework for clinical sample handling and traceability.
• Lead deviation, CAPA, and internal audit programs.
• Lead data integrity governance and validation of computerised systems.
• Support regulatory inspections and due diligence.
• Assist with compliance across ethics, biosafety, OHS and incident reporting.
• Contribute to quality initiatives across the lab and organisation.

Skills

Quality management

GxP compliance

Audit management

CAPA

Document control

Data integrity

Vendor qualification

Training records

Change control

Risk assessment

Education

Bachelor's degree in science

Job description

At Audax, our mission is to cure disease by harnessing the entire immune system. We are seeking a passionate and dedicated Quality Manager to oversee quality systems across our discovery and development programs.

Based at our labs and offices in the Alfred Hospital Precinct in Melbourne, this role reports to the Chief Operating Officer and works closely with the Operations team, to champion quality, compliance and continuous improvement across the organisation.

As Audax grows, you will help shape and maintain a fit-for-purpose QMS that supports our cutting-edge research and development activities. This includes ensuring records are robust and defensible, vendors are appropriately qualified and monitored, and systems are in place to provide the traceability expected for clinical development.

This role will suit candidates who understand the importance of quality and compliance, while maintaining a practical and risk-based approach that keeps systems proportionate to the company's stage of development.

What you'll do:

Oversee the Quality Management System, including document control, maintenance of quality records and associated registers.

Develop quality systems and documentation in a stage-appropriate and risk-based manner proportionate to the company's stage of development.

Own training and competency records, and coach scientists in good documentation practice so that quality controls are understood rather than imposed.

Qualify and monitor performance of external providers, including contract manufacturers and clinical and laboratory service providers, through quality agreements and audit.

Build the quality framework for clinical sample handling, covering receipt, chain of custody, storage, reconciliation and traceability to the reported result.

Establish and run the deviation and corrective action processes, and lead an internal audit program across research, clinical and external activities.

Lead data integrity and electronic records governance, including audit trail review, user access management and validation of computerised systems.

Support regulatory inspection and partner due diligence as required, and advise leadership on quality requirements proportionate to the stage of the company.

Assist with compliance record-keeping across ethics, biosafety, OHS and incident reporting.

Contribute to quality and operational initiatives across the laboratory and broader organisation, supporting the systems, records and processes that enable effective and compliant operations.

To qualify for the role:

A degree (or equivalent qualification) in a science or related discipline, together with at least four years' experience in a quality role supporting laboratory research, manufacturing, clinical trials or bioanalysis.

Flexible, collaborative attitude with a willingness to contribute across the organisation to support high performance and team success.

Practical experience across the core elements of a QMS, including document control, training, deviations and CAPA, change control and internal audit. Experience building or refining quality systems within a small or growing organisation would be highly regarded.

Working knowledge of ICH guidelines and GxP principles relevant to biotechnology product development, including sponsor oversight responsibilities. Familiarity with PIC/S GMP requirements for investigational medicinal products is desirable.

Demonstrated understanding of confidentiality, privacy and information management practices.

Experience overseeing QA aspects of outsourced research, development, manufacturing and clinical service providers, including supplier qualification, risk assessment, quality agreements, sponsor oversight and audit activities.

Experience with data integrity principles, including ALCOA+, audit trail review and computerised system validation, is highly regarded.

Laboratory experience sufficient to establish controls for sample receipt, chain of custody, storage and traceability, with strong record-keeping skills and experience using electronic lab notebooks.

Excellent written and verbal communication skills, including the ability to develop clear, practical procedures for users with limited quality or compliance experience.

Strong planning and organisational skills, with the ability to prioritise competing demands and apply quality controls proportionate to risk and stage of development.

Applicants must have valid working rights in Australia.