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 (Melbourne)
🏢 Veritus Research
📍 Melbourne