Our client is an ASX-listed Australian biotechnology company focused on developing innovative therapies for cancer and fibrotic diseases. Based in Melbourne, the company is advancing a pipeline of targeted small-molecule drugs, with a particular emphasis on focal adhesion kinase (FAK) inhibitors. Its lead candidate is currently in clinical development for pancreatic cancer, alongside additional programs exploring applications in other cancers and fibrotic conditions.
The Opportunity
The Quality Manager is a critical leadership role responsible for establishing, maintaining, and continuously improving the organisation's quality framework across all stages of the product lifecycle. This is a hands-on, strategic position suited to a quality professional who can balance rigorous compliance with the flexibility and resourcefulness required in a lean, fast-paced biotech environment:
* Develop and execute the organisation's quality strategy, aligned with product development milestones, clinical study requirements, and commercialisation objectives
* Oversee the design, implementation, and ongoing maintenance of the Quality Management System (QMS) in accordance with ISO, cGMP, ICH guidelines, and applicable global standards.
* Serve as the organisational authority on all quality-related matters, providing strategic guidance and direction to senior management and the Board
* Plan, coordinate, and facilitate internal, supplier, and regulatory audits, ensuring timely and effective resolution of all findings
* Build and oversee the CAPA system and change control process, ensuring root cause analyses are thorough and corrective actions are implemented effectively and on time
* Lead quality risk management activities across the product lifecycle in accordance with ICH Q9 and ISO 14971 principles
* Partner with R&D, manufacturing, clinical, regulatory, and commercial teams to integrate quality requirements into all operational and strategic activities
* Design and deliver quality training programs to build awareness, competence, and compliance across the organisation
* Prepare and present quality metrics, reports, and strategic updates to senior management and the Board of Directors
The Requirements
* Tertiary qualification in life sciences, medical technology, biomedical engineering, or a closely related discipline
* Minimum 5 years' experience in a quality management role within the biotech, diagnostics, pharmaceutical, or medical device industry
* Demonstrated experience implementing, maintaining, and improving a QMS in a regulated environment
* Proven track record in achieving or maintaining relevant certifications or accreditations (e.g., ISO 9001:2015, cGMP)
* Strong working knowledge of global quality and regulatory standards applicable to therapeutic and medical product development, including ISO 9001:2015, ISO 14971, cGMP, and ICH guidelines
* Experience managing audits (internal, external, and regulatory), CAPA systems, document control, and change control processes
* Demonstrated leadership capability, including the ability to influence, coach, and develop team members and cross-functional stakeholders
* Hands-on experience in pharmacovigilance operations, including case processing, safety reporting and databases (e.g., Argus or similar systems)
* Postgraduate qualification in quality management, regulatory affairs, or a related field
* Experience supporting clinical study quality requirements or regulatory submissions
* Familiarity with electronic QMS platforms and digital quality tools
* Experience working in a start-up or scale-up biotech environment
#J-18808-Ljbffr