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 elevate 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
* 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
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.
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