Salary: $100,000 - $120,000 (excluding superannuation)

Join a leading clinical research organisation and play a pivotal role in driving quality, compliance, and continuous improvement.

Scientia Clinical Research Ltd is a dedicated, not-for-profit, early-phase (Phase 1) clinical trials facility, that conducts studies for healthy volunteers and patients in areas like oncology. We are located at the Prince of Wales Hospital campus, Randwick NSW, and are equipped with an on-site laboratory, pharmacy, and a specialized cleanroom for compounding and manufacturing. We focus on first-in-human studies and collaborate with local research institutions to translate pre-clinical research into clinical trials.

Scientia Clinical Research (SCR) is seeking an experienced and detail-oriented Senior Quality Assurance Associate to join our growing team. This is a full-time role. This is an exciting opportunity for a quality professional who is passionate about clinical research excellence, regulatory compliance, systems and procedures improvements, quality systems, and continuous improvement.

Working closely with Clinical Operations, Medical, Research, Corporate Services, Sponsors, CROs, and regulatory authorities, you will help maintain and enhance quality standards across all areas of the organisation. You will play a critical role in ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and internal quality standards while supporting the successful delivery of both Healthy Volunteer and Oncology clinical trials.

This role is ideally suited to an individual with experience in clinical research quality assurance who enjoys partnering with stakeholders, driving process improvements, and fostering a culture of quality and compliance within a dynamic and highly regulated environment.

About the Role

As a Senior Quality Assurance Associate ,



you will play a central role in maintaining and continuously improving Scientia's Quality Management System (QMS), supporting inspection readiness, and promoting best practice across the organisation. Working closely with operational and corporate teams, you will provide expert guidance on quality and compliance matters while ensuring adherence to ICH-GCP, GxP principles, regulatory requirements, systems and improvements and company procedures.

You will lead and support a broad range of quality assurance activities, including SOP development and review, audit and inspection readiness, quality investigations, CAPA management, risk management, and quality oversight programs. Acting as a trusted advisor to stakeholders across the business, you will help identify compliance risks, implement practical solutions, and drive initiatives that strengthen operational effectiveness and quality outcomes.

In this role, you will oversee electronic quality systems, support computer system validation activities, manage document lifecycle processes, and contribute to governance and vendor oversight programs. You will coordinate and host sponsor and regulatory audits, analyse quality metrics and compliance trends, support staff training and capability development, and ensure the organisation remains inspection-ready at all times.

This is a highly collaborative role suited to someone who thrives in a fast-paced clinical research environment and is passionate about creating sustainable quality systems that support research excellence, participant safety, and regulatory compliance.





What You'll Bring

- Degree qualification in Life Sciences, Healthcare, Pharmacy, Nursing, or a related discipline.
- Minimum 2-3 years' quality assurance experience within a pharmaceutical, biotechnology, CRO, healthcare, or clinical research environment.
- Strong knowledge of ICH-GCP, GxP principles, quality management systems, and clinical research regulations.
- Experience supporting audits and inspections, managing SOPs, investigations, CAPAs, and continuous improvement activities.
- Proficiency with eQMS and quality reporting systems; exposure to CSV and vendor qualification activities is desirable.
- Strong analytical, organisational, communication, and stakeholder management skills.
- Exceptional attention to detail, a collaborative approach, and the ability to manage multiple priorities.

Most importantly, you'll bring a proactive mindset and a commitment to quality, compliance, and continuous improvement. Why Join SCR?

- Be part of a growing and innovative clinical research organisation.
- Work alongside experienced quality, operational, and research professionals.
- Play a critical role in maintaining and advancing quality excellence across the organisation.
- Contribute to meaningful clinical research that improves patient outcomes.
- Enjoy a collaborative, supportive, and values-driven team environment.
- Access ongoing professional development and career growth opportunities.
- Help shape and strengthen quality systems that support leading Healthy Volunteer and Oncology clinical research programs.

If you are passionate about quality, compliance, and continuous improvement, and you're looking for an opportunity to make a meaningful impact within a agile clinical research environment, we'd love to hear from you. Applications open: 7 August 2026

Applications close: 7 September 2026

📌 Senior Quality Assurance Associate (Southern Sydney)
🏢 Scientia Clinical Research
📍 Southern Sydney