Quality Manager - Clinical Research

Evolve Scientific; Sydney; On-site; AUD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Evolve Scientific is seeking a Quality Manager to lead the Quality Management System and partner with senior leadership to ensure top industry standards in quality and compliance.

You will drive continuous improvement, mentor the quality team, and shape a quality-first culture as the CRO expands.

Qualifications

• Must have experience in clinical research quality and compliance.
• Strong knowledge of ICH-GCP and clinical trial regulations.
• Experience with audits, CAPAs, SOP management and QMS oversight.
• Ability to balance strategic thinking with hands-on execution.

Responsibilities

• Lead and continuously improve the Quality Management System (QMS).
• Develop, review and maintain SOPs and controlled documentation.
• Manage internal and external audit activities.
• Oversee quality events, investigations, deviations and CAPAs.
• Provide expert guidance on GCP interpretation and clinical research compliance.
• Support inspection readiness and regulatory compliance initiatives.
• Drive continuous improvement projects across the business.
• Partner with stakeholders across all functions to strengthen quality processes.
• Mentor and support the development of junior quality team members.
• Contribute to the growth and evolution of the overall quality function.

Job description

Quality Manager

Clinical Research | Quality & Compliance

Exciting Opportunity to Shape Quality in a Growing Clinical Research Organisation

Evolve Scientific is partnering with a rapidly expanding clinical research organisation to recruit a Quality Manager. This is a rare opportunity to join a business at an exciting stage of growth and play a pivotal role in shaping its quality function, systems, and culture.

If you're passionate about clinical research quality, participant safety and continuous improvement, and are looking for a position where you can genuinely make an impact, this could be the ideal next step.

About the Role

This is a highly visible role with broad influence across the organisation. You'll take ownership of the Quality Management System (QMS) and work closely with senior leadership to ensure the business continues to meet the highest standards of quality, compliance and operational excellence.

The successful candidate will be empowered to drive meaningful change, implement improvements, mentor team members and help build a quality-first culture as the organisation continues to grow.

Key Responsibilities

• Lead and continuously improve the Quality Management System (QMS)
• Develop, review and maintain SOPs and controlled documentation
• Manage internal and external audit activities
• Oversee quality events, investigations, deviations and CAPAs
• Provide expert guidance on GCP interpretation and clinical research compliance
• Support inspection readiness and regulatory compliance initiatives
• Drive continuous improvement projects across the business
• Partner with stakeholders across all functions to strengthen quality processes
• Mentor and support the development of junior quality team members
• Contribute to the growth and evolution of the overall quality function

About You

You are a proactive quality professional who enjoys working in a dynamic environment and can confidently contribute from day one.

You'll bring:

• Strong experience in clinical research quality and compliance
• Excellent working knowledge of ICH-GCP and clinical trial regulations
• Experience with audits, CAPAs, SOP management and QMS oversight
• Strong stakeholder engagement and relationship-building skillsThe ability to balance strategic thinking with hands-on execution
• A passion for driving quality excellence and participant safety

Experience within CROs, sponsors, clinical trial site networks, hospitals, healthcare organisations and academic research institutions will be highly regarded.

Why Apply?

• Join a growing organisation where your contribution will be highly visible
• Opportunity to influence quality strategy, systems and culture
• Make a tangible impact on clinical research quality and patient outcomes
• Work closely with senior leadership and key stakeholders
• Supportive, collaborative and purpose-driven environment
• Competitive salary package