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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Chance Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

📌 Senior Quality Associate (Australia)
🏢 CSL Innovation
📍 Australia