Senior Quality Associate

CSL; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

CSL Melbourne is seeking an experienced Senior Quality Associate to support quality and compliance activities across CSL’s clinical development and IMP portfolio. You will act as a front-line quality partner to Technical Product Development teams, providing GMP/GxP oversight across development, manufacture, and quality systems.

The role is onsite at our Elizabeth Street Melbourne office and offers exposure to clinical trial manufacturing, deviations management, CAPAs, change control, QRAs, and

Qualifications

• Degree in a relevant biological or scientific discipline.
• Minimum 3 years’ experience in GMP manufacturing, Quality Assurance, Regulatory Affairs, or Process/Technical Development.
• Experience supporting clinical trial GMP manufacture is highly desirable.
• Strong working knowledge of GMP/GxP requirements.
• Excellent communication skills with the ability to influence across technical and non‑technical teams.

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

Skills

GxP knowledge

Deviation management

CAPA management

Change controls

Technical communication

Analytical thinking

Independent work

Collaboration

Education

Degree in biological or scientific discipline

Job description

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.
• Strong 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.
• Collaborative, customer‑focused mindset