Auditor - GCP & GLP x2
Entity: CSL Behring
Job Category: Quality
Job Family: Clinical Quality
Job Type: Full Time
Location: Melbourne, Victoria, Australia
Employer Reference: R-275286
Job Description
We are seeking an experienced GLP and GCP Auditor to join our R&D Quality Assurance Audit Services team. This role is responsible for executing the global R&D Quality audit program, with a strong focus on external audits across clinical research, pharmacovigilance, systems, and vendor environments.
You will assess the integrity and quality of scientific data, ensure compliance with applicable regulations and CSL standards, and work collaboratively with Quality and functional stakeholders to drive inspection readiness and continuous improvement.
This role will require 50% of travel around the APAC region.
NOTE – There are 2 positions available, one for GLP and the other for GCP
Key Responsibilities
Execute the global R&D QA audit program across assigned GxP disciplines
Conduct external audits of CROs, vendors, investigator sites, E-Systems, databases, and ECs/IRBs
Support internal audits and self‑inspections as required
Prepare clear, risk‑based audit reports with CAPA recommendations
Identify non‑compliance trends and escalate systemic risks to relevant stakeholders
Partner with Quality and functional teams to drive continuous improvement in audit and inspection practices
Maintain current knowledge of GxP regulations, industry standards, and regulatory trends
Contribute to the Audit Services Community of Practice and audit capability building
Your Experience
Bachelor’s degree in a scientific or related discipline
3+ years’ Quality Assurance experience in GCP or GVP
(experience in other GxP environments will be considered)Experience conducting or supporting audits and inspections
Experience with OECD principles, ICH guidelines, ISO standards
Solid understanding of QMS and regulatory frameworks
Strong analytical, problem‑solving, and risk‑based judgement skills
Excellent written and verbal communication skills
Confident working independently and across global, multi‑cultural teams
Organised, adaptable, and comfortable working in a travel‑intensive role
Aptitude to digital systems - AI Bots would be desirable
How to Apply
Please submit your application including your updated resume and a cover letter.
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 Opportunity 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.