We are seeking an experienced Senior Quality Associate to support quality and compliance activities across CSL’s clinical development and investigational medicinal product (IMP) portfolio.
In this role, you will act as a front‑line quality partner to Technical Product Development teams, providing GMP/GxP oversight across development, manufacture, and quality systems. You will manage deviations, investigations, CAPAs, change controls, and product technical complaints, while supporting continuous improvement and inspection readiness.
This role offers strong exposure to clinical trial manufacturing, cross‑functional project teams, and global quality systems.
This role is onsite and will be based at our Elizabeth street Melbourne office.
Key Responsibilities
- Provide quality leadership and guidance to IPT project and delivery teams.
- Manage deviations, OOS investigations, and CAPAs, including complex issues, through to closure.
- Facilitate and manage change controls and change panel meetings.
- Manage product technical complaints and associated investigations.
- Conduct self‑inspections, report findings, and assess responses.
- Review and approve technical and product documentation.
- Support and participate in Quality Risk Assessments (QRAs)
- Provide GxP and QMS training and coaching to technical teams.
- Establish and maintain local and global Quality Agreements
- Support continuous improvement initiatives across Technical Product Development
Your Experience
- Degree in a relevant biological or scientific discipline
- Minimum 3 years’ experience in one or more of:
- GMP manufacturing
- Quality Assurance
- Regulatory Affairs
- Process or Technical Development
- Experience supporting clinical trial GMP manufacture is highly desirable.
- Robust working knowledge of GMP/GxP requirements
- Confident managing deviations, investigations, CAPAs, and change controls.
- Excellent communication skills with the ability to influence across technical and non‑technical teams.
- Strong problem‑solving and analytical capability
- Self‑motivated, organized, and able to work independently.