Description

Clinical Quality Associate/Senior Associate

The Opportunity

This is a unique opportunity to step into a high-impact quality role within the Adjutor Group which comprises both Adjutor Clinical and Adjutor Healthcare.

You will support and enhance a service-based company Quality Management System by working closely with the Quality Manager, Heads of Clinical and Development Regulatory and Commercialisation, Business Development and Corporate teams, to ensure compliance across the business, with an emphasis on clinical trial projects.

Adjutor has been rapidly growing since 2018 and operates in Australia, New Zealand and Hong Kong. 

We are proud of our inclusive and collaborative company culture and values which include Respect- We treat every person with dignity, fairness, and genuine care; Integrity-We act honestly and ethically in everything we do; Agility-We adapt, respond, and move forward with purpose and efficiency; Accountability- We own our actions, our outcomes, and our impact; Reliability- We do what we say consistently, carefully, and on time; Resourcefulness- We find a way creatively, practically, and collaboratively.

Key responsibilities of the role

• -          Accountable for Clinical project quality assurance and compliance to ICH GCP, ISO14155 and other relevant regulations, as applicable.
• -          Maintain and continuously improve the Quality Management System (QMS)
• -          Conduct internal and support external audits and assessments
• -          Assist with the planning and support of regulatory inspections
• -          Evaluate and manage third party vendors for clinical trial services
• -          Ensure data integrity, privacy, and cybersecurity compliance
• -          Manage CAPAs, deviations, and change controls, as required
• -          Assist in incident trend reporting, analysis and oversight of continuous improvement systems
• -          Participate in client-facing audit and compliance reviews
• -          Have input into project review meetings and provide information for Management Review Meetings
• -          Manage risk for clinical systems and processes
• -          Deliver and track training on relevant clinical regulatory guidelines, clinical competencies and quality systems as required.
• -          Assist in the development, review, and implementation of policies, procedures, and quality documentation
• -          Provide backup to the Quality Manager to ensure operational continuity

Requirements

• -          Experience in Clinical QA
• -          Strong auditing and vendor assurance experience
• -          Exposure to cybersecurity, data integrity, and privacy aspects of audits
• -          Solid background in risk and governance
• -          Familiarity with QMS processes and GxP

Role Details

Location: Melbourne or Sydney (remote with some on-site client work)

Reports to: Quality Manager

Employment: Initially 3 days per week (with possibility of increasing overtime)

Is this your next role?

If you are interested in the role, we'd love to hear from you. Apply today or reach out to learn more about the team and what this role looks like day-to-day by sending a cover letter & a current resume to contact@adjutor.com.au.