Senior Quality Assurance Coordinator

Operating for more than 30 years, CMAX is Australia’s longest running and most experienced clinical trial units conducting successful world‑leading research for local and international clients, specialising in a range of early‑phase trials and first‑in‑human studies.

We are proud to be a key contributor in the advancement of global medicines and technologies - from vaccines and pain control to early warning bio‑devices and hormone replacement therapies, these are just a few of the many research areas for which CMAX has provided clinical trial services.

Employing more than 400 staff, CMAX is a 78‑bed clinical trials unit, with a database of more than 60,000 clinical trial participants, and utilising state‑of‑the‑art facilities, we are primely positioned, opposite the Royal Adelaide Hospital and part of the Adelaide Bio Med City precinct.

We are seeking a Senior Quality Assurance Coordinator (SQAC) to join our QA team and lead the coordination of quality systems, policies and compliance activities in line with CMAX/Fusion procedures, SOPs and regulatory requirements. This role provides senior guidance on quality matters, supports continuous improvement initiatives and ensures inspection‑ready standards across the organisation.

This is a full‑time, permanent Monday‑Friday role. Occasional flexibility for after‑hours or weekend work may be required. The position is split across two sites: three days at our Fusion Norwood location and two days at our CMAX City site on North Terrace.

• Coach and develop junior staff, as applicable, to achieve project targets and to build a successful team;
• Act in the capacity of a mentor;
• Identify and coordinate or facilitate training and development needs;
• Demonstrate a commitment to own learning and development and actively contribute to a culture of learning at CMAX/Fusion;
• Oversee the Quality Assurance Team during QA Manager absence as needed;
• Take a hands‑on role in establishing, maintaining and monitoring the Quality Management System (QMS), under QA Manager supervision at the Fusion site;
• Assist the QA Manager in the maintenance and monitoring of the current CMAX Quality Management Systems and overseeing the implementation and continuous improvement of an electronic Quality Management System (e‑QMS) and initiatives to ensure compliance with relevant ICH GCP and local regulatory requirements;
• Coordinate document control activities, including the Standard Operating Procedures (SOPs), SOP Deviations, Controlled Form and Work Instruction systems;
• Coordinate Quality Incidents and Corrective Action Preventive Action (CAPA) processes and activities;
• Oversee the policy review process;
• Ensure CMAX/Fusion QA records are accurate, current and inspection ready;
• Coordinate and assist with the provision of quality reviews of key CMAX/Fusion study documentation including the Study Protocol, Source Documents and Investigator Site Files;
• Coordinate reports /summaries for external stakeholders, specially sponsors and CROs, and internal committees;
• Coordinate the execution of the CMAX/Fusion annual audit programme;
• Coordinate the planning and conduct of pre‑study and/or on‑study site audits, internal, external, desktop and service providers audits to ensure that studies can be and/or are performed and data can be and/or are being generated/recorded in accordance with applicable Australian and overseas regulatory guidelines (including ICH‑GCP), the relevant organisational Standard Operating Procedures and with the Study Protocol;
• Coordinate, write, review and follow‑up audit reports generated by external audits or inspections;
• Coordinate Regulatory Compliance Oversight Inspections;
• Identify quality risks and trends and escalating issues to the QA Manager with recommended corrective actions;
• Coordinate the development, delivery and maintenance of internal/external quality related training presentations;
• In conjunction with the QA Manager identify, develop and delivery of QA related training material;
• Coordinate the review and maintain departmental quality documents e.g.;
  Business Continuity Plans;
• Participate and provide regular quality updates…