The Quality Manager is accountable for the operational performance of the Veritus Research quality management system. The role converts quality data into decisions the business can act on, and holds the organisation to the standard of evidence that regulators, sponsors and participants expect. Reporting to the Head of Quality, the Quality Manager leads the non-conformance and CAPA programme, the internal and external audit programme, and the operational quality partnership with each functional unit. The role carries direct responsibility for executing the transition of the quality system from ICH GCP E6(R2) to E6(R3) and for demonstrating sustained compliance with the revised standard thereafter. The Quality Manager leads the quality team, with the Senior Quality Associate and Quality Associate reporting to this role.

Benefits of the Role

- Join a fun, innovative, and motivated team - we work to support each other to grow our business
- Free on site parking available
- Training will be provided by your manager
- Plenty of opportunities for varied work and career development

Key responsibilities

- Lead execution of the approved E6(R3) transition plan, holding action owners to agreed milestones and reporting schedule variance to the Head of Quality as it arises
- Translate E6(R3) requirements into controlled documents, system configuration and role level training, so that obligations land in day-to-day practice
- Maintain a live compliance position against E6(R3), identifying open gaps, owners and closure timelines, with particular attention to data governance, computerised system validation,



and risk proportionate quality management
- Hold accountability for the non-conformance lifecycle end to end, from notification and triage through investigation, CAPA assignment, closure and effectiveness check
- Own the risk classification and escalation decision for every non-conformance, determining the escalation pathway and the level of corrective action required
- Own the annual internal audit schedule, ensuring audits are resourced, delivered on time, and reported with findings that are graded, evidenced and actionable
- Manage the external audit programme, acting as the Veritus Research host for sponsor audits, CRO audits and site qualification visits
- Establish and maintain the quality data set for Veritus Research, defining each metric, its source, its collection method, its owner and its reporting frequency
- Establish an active quality partnership with each operational unit, being medical, projects, clinical, pharmacy, laboratory and start-up
- Lead, develop and performance manage the Senior Quality Associate and the Quality Associate

About you

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




- Minimum 5 years' experience in a regulated industry, for example an workplace overseen by the TGA, Medsafe, FDA or EMA
- At least 2 years in a quality or operational management role
- Working knowledge of a recognised quality framework, for example GMP, GCP, GCLP or an ISO standard
- Proven capability to bring operational teams together, influence practice across disciplines, and hold others to a standard without relying on positional authority
- A track record of accountability for delivery to a documented standard, and of improving how a team works, with evidence that the improvement held
- Experience investigating problems to root cause and implementing corrective action
- Direct experience of audit, monitoring or inspection, whether conducting it, hosting it, or preparing an area for it
- Strong analytical skills, with the ability to build, interrogate and present a data set that stands up to challenge
- Australian or New Zealand Citizen, Permanent Resident, or appropriate work visa

About us

Veritus Research improves world health by expertly managing clinical trials to accelerate medical advancements.

We are a standalone Phase I to IV clinical research unit in Bayswater, running clinical trials for sponsors and CROs across Australia and internationally. Our purpose-built facility and dedicated clinical team let us take a study from first-in-human dosing through to database lock, with participant safety and data integrity at the forefront of everything we do.

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📌 Quality Manager (Knox City)
🏢 Veritus Research
📍 Knox City