Senior Quality Associate Preclinical & Laboratory Quality

We are seeking an experienced Senior Quality Associate to join our PreClinical Laboratory Quality Assurance team in Melbourne. This is an exciting opportunity to contribute to the quality and compliance framework supporting preclinical and laboratory operations across research and development activities.

The Opportunity

Reporting to the PreClinical Laboratory Quality Assurance Lead you will play a key role in ensuring compliance with Good Laboratory Practice (GLP) Good Clinical Laboratory Practice (GCLP) ISO/IEC 17025 and other applicable quality requirements. You will partner closely with R&D teams to support quality systems inspection readiness regulatory compliance and continuous improvement initiatives.

This role is a hybrid role which will be based at our Elizabeth St office in Melbourne.

Key Responsibilities

In this role you will:

• Support the implementation and maintenance of quality systems and compliance processes across preclinical and laboratory functions.

• Partner with R&D stakeholders to establish and maintain quality procedures standards and systems.

• Review and approve study plans protocols reports and supporting documentation to ensure GLP/GCLP compliance.

• Conduct quality inspections including facility study process document and ISO 17025 inspections.

• Support internal and external regulatory inspections and audit activities.

• Manage and facilitate deviations change controls and corrective and preventive actions (CAPAs).

• Assess quality risks and provide guidance on compliance-related matters.

• Review assay method development and equipment validation documentation.

• Support key quality metrics and reporting activities.

• Promote a strong quality culture and drive continuous improvement across the organisation

About You

To be successful in this role you will bring:

Qualifications

• Degree in Biological Sciences Life Sciences or a related scientific discipline.

Experience

• Experience working within GLP GCLP GxP Quality Assurance laboratory or process development environments.

• Knowledge and practical application of quality systems and compliance frameworks.

• Experience supporting quality activities within R&D product development laboratory or regulated environments.

• Strong understanding of GLP requirements and quality principles.

• Knowledge of ISO/IEC 17025 laboratory requirements.

• Excellent planning organisational and stakeholder management skills.

• Strong communication presentation and influencing abilities.

• Proven ability to identify opportunities for continuous improvement and drive positive outcomes.

• Customer-focused approach with strong problem-solving and decision-making capabilities.

Why CSL

At CSL youll have the opportunity to work alongside talented professionals in a purpose-driven environment where your contributions make a real impact. We offer:

• Meaningful work that improves patient lives globally.

• Career development and growth opportunities.

• A collaborative and inclusive culture.

• Access to world-class research quality and manufacturing environments.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Senior IC