Auditor - GLP

Quality in preclinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a GLP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of non-clinical safety/toxicology studies trial data and compliance with legal and corporate standards. By conducting audits of our external vendors (GLRP, GLP and GcLP) and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our non-clinical research. We are looking for an experienced auditor who can navigate complex pre-clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.

Main Responsibilities

• Audit Execution: Conduct assigned external audits of non-clinical facilities and safety laboratories.

• Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.

• Trend Analysis: Identify non-compliance trends and systematic risks within the Non-clinical (GRLP/GLP/GCLP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.

• Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for non-clinical trial management.

• Regulatory Knowledge: Maintain up-to-date knowledge of global GLP regulations (ICH Safety Guidleines) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all non-clinical development programs.

Position Qualifications & Experience:

• Academic Background: BS degree in relevant biological science, science, or related discipline

• Professional Experience: 3 years of Quality Assurance experience within a pre-clinical and safety laboratory environment, demonstrating a strong understanding of preclinical trials, monitoring, and regulatory frameworks.

• Audit Expertise: Experience in preclinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the preclinical research discipline.

• Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with external vendors providing relevant services.

• Working Knowledge of:

  • OECD principles of GLP

  • ICH Safety Guidelines

  • ICH M3(R2) Guideline

  • ICH M10 Guideline

  • 21 CFR Part 58 – Good Laboratory Practice (GLP)

  • Directives 2004/9/EC and 2004/10/EC (GLP Directives)

• Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.

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.