Clinical Quality Manager

About the Company

The organisation runs early-phase and first-in-human clinical trials, where new treatments are tested in people during the earliest stages of development.

Managing clinical trials for sponsors and CROs across Australia and internationally. Its purpose-built facility and dedicated clinical team support studies from first-in-human dosing through to database lock, with participant safety and data integrity central to its work.

About the Role

Seeking a Quality Manager to lead the operational performance of its quality management system and support the delivery of high-quality clinical trials. Reporting to the Head of Quality, you will lead the non-conformance and CAPA programme, manage internal and external audits, and work closely with operational teams to embed quality into everyday practice.

A key priority will be delivering the transition from ICH GCP E6(R2) to E6(R3) and demonstrating sustained compliance with the revised standard.

You will also lead and develop a Senior Quality Associate and a Quality Associate.

Pay range and compensation package

• Working arrangements: Full-time, with the option of a four-day working week.
• Salary will be pro rata for a four-day arrangement.

Responsibilities

• Lead the approved ICH GCP E6(R3) transition plan, tracking milestones and reporting any delays to the Head of Quality.
• Translate E6(R3) requirements into controlled documents, system configuration and role-specific training.
• Maintain oversight of compliance gaps, action owners and closure timelines, particularly across data governance, computerised system validation and risk-proportionate quality management.
• Manage the full non-conformance lifecycle, including notification, triage, investigation, CAPA assignment, closure and effectiveness checks.
• Determine risk classifications and escalation pathways for non-conformances.
• Own the annual internal audit schedule, ensuring audits are appropriately resourced, delivered on time and supported by clear, evidence-based findings.
• Manage external audits and host sponsor audits, CRO audits and site qualification visits.
• Establish and maintain quality metrics, defining data sources, collection methods, ownership and reporting frequency.
• Build effective quality partnerships across medical, projects, clinical, pharmacy, laboratory and study start-up teams.
• Lead, develop and manage the performance of the Senior Quality Associate and Quality Associate.

Qualifications

• Tertiary qualification in Science, Life Sciences, Nursing, Pharmacy, Healthcare or Quality Management.

Required Skills

• At least five years’ experience in a regulated industry, such as an environment overseen by the TGA, Medsafe, FDA or EMA.
• At least two years’ experience in a quality or operational management role.
• Working knowledge of a recognised quality framework, such as GCP, GMP, GCLP or an ISO standard.
• Proven ability to bring operational teams together, influence practice across disciplines and maintain standards.
• A track record of delivering to documented standards and implementing lasting improvements.
• Experience conducting root cause investigations and implementing corrective actions.
• Direct experience conducting, hosting or preparing for audits, monitoring visits or inspections.
• Strong analytical skills, with the ability to build, assess and present reliable quality data.
• Australian or New Zealand citizenship, permanent residency or an appropriate work visa.

Preferred Skills

• Supportive, motivated and innovative team.
• Training and support from your manager.
• Varied work and opportunities for career development.

If you are intrested please reach out to Brian at [email protected]