At Southern CDC, we partner with sponsors and sites across the clinical trials landscape to deliver high-quality, compliant clinical research outcomes. We’re building a reputation for operational excellence and regulatory rigour across Australia and the globe. We're passionate about doing clinical trials right, and we're looking for someone who shares that passion to join our Quality team.

Are you ready to help safeguard the integrity of our processes and support a culture of continuous improvement?

About the Role The QA Associate / Auditor plays a pivotal role in upholding the highest standards of excellence within our organisation. Responsible for meticulously examining and ensuring compliance with regulatory standards, study protocols and company procedures, our QA team safeguards the integrity of everything we do. This position requires a keen eye for detail, an analytical mindset, and a solid understanding of quality standards and procedures relevant to clinical research.

Whether auditing internal processes or assessing external vendor compliance, your contributions will be crucial in maintaining and enhancing our reputation for quality.

Responsibilities & Duties

- Conduct periodic audits and assessments of quality management systems and processes
- Review and verify compliance with regulatory standards, clinical trial protocols and internal Standard Operating Procedures
- Identify areas of non-compliance and recommend corrective actions
- Document audit findings and prepare detailed reports for management
- Collaborate with various departments to ensure quality standards are met and maintained
- Develop and update quality control processes and procedures, in collaboration with department leaders and subject matter experts
- Assist with coordination of external auditors / facilitate external audits, as applicable
- Monitor the implementation and effectiveness of corrective and preventive actions (CAPA)
- Analyse data to identify trends and areas for improvement




- Summarise trend analysis and recommendations for internal stakeholders
- Train staff on quality assurance policies, procedures, and industry best practices
- Assist in developing quality assurance goals and objectives

Qualifications & Skills

Required:

- Bachelor's degree in Quality Assurance, Science, or a related field
- Minimum 3 years' experience in R&D;, pharmaceutical manufacturing, biotech, medical or laboratory settings, with some exposure to quality assurance or auditing
- Experience with ISO 9001 or other relevant quality management systems within pharmaceutical, biotech, medical device or manufacturing industries
- Knowledge of regulatory standards (including ICH-GCP, GxP, FDA, TGA and EMA) and compliance requirements
- Proficiency in data analysis and statistical methods
- Excellent communication and interpersonal skills, written and verbal
- Strong analytical and problem-solving skills
- Attention to detail and a commitment to maintaining high standards
- Proficient in Microsoft Office Suite

Desirable:

- Certified Quality Auditor (CQA) certification
- Experience with Atlassian Confluence and Jira
- Experience in continuous improvement methods (Kaizen, Lean, Six Sigma, 5S)
- Internal auditor / lead auditor certification (ISO 9001 / ISO 13485 / MDSAP)

Attributes:

- Inquisitive mindset with the ability to think laterally
- Self-driven, reliable, and willing to take ownership
- Strong organisational and time management abilities
- Comfortable working both independently and collaboratively across cross-functional teams

Why Join Southern CDC?

- Be part of a growing, purpose-driven organisation making a genuine impact in clinical research across Australia and the Globe
- Join a collaborative team culture that values quality, integrity, and continuous improvement
- Enjoy a competitive compensation package and opportunities for career growth
- Hybrid and versatile working arrangements to support work/life balance
- Genuine career development pathways within a growing clinical trials organisation
- Contribute directly to the safe and compliant delivery of clinical trials that improve patient outcomes

📌 Quality Assurance Associate (Melbourne)
🏢 Southern Clinical Development Consulting
📍 Melbourne