External Audit Specialist

The Opportunity

Join our Research & Development Quality audit program as an External Audit Specialist, supporting the execution of the global audit plan and helping ensure clinical trial data integrity and adherence to applicable legal, regulatory, and company requirements.

The role involves auditing clinical investigator sites, external service providers, and internal trial management activities to identify compliance gaps, recurring issues, and risks that may affect the reliability of clinical research. We are looking for an experienced auditor who can operate effectively in complex clinical settings and collaborate with stakeholders to establish corrective actions that deliver sustainable improvements.

The Role

• Audit Execution: Perform assigned audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
• Audit Reporting & Risk Assessment: Prepare detailed Audit Reports, classify observations according to risk, and provide recommendations for appropriate corrective and preventive actions (CAPA) addressing trial conduct and data integrity.
• Compliance Trend Analysis: Evaluate recurring compliance issues and systemic risks across the Clinical (GCP) area and communicate relevant findings to line management and clinical functional leaders to strengthen trial quality.
• Continuous Improvement: Support improvements to standard operating procedures (SOPs) for audit activities and collaborate with stakeholders to implement risk-based, compliant approaches for clinical trial management and monitoring.
• Regulatory Expertise: Keep current with worldwide GCP requirements, including ICH E6, as well as relevant industry developments, and identify emerging requirements to maintain quality across clinical development programs.

Skills and Experience

• Education: BS degree in biological sciences, science, or another relevant discipline.
• Professional Experience: At least 3 years of Quality Assurance experience in a GCP-regulated environment, with demonstrated knowledge of clinical trial phases, monitoring activities, and applicable regulatory requirements.
• Audit Expertise: Practical experience conducting clinical audits and supporting inspection management, together with a strong understanding of Quality Assurance requirements within clinical research.
• Communication & Collaboration: Strong interpersonal, negotiation, and communication abilities, with proven capability to work effectively with multinational clinical teams, investigators, and external CRO partners.
• Working Knowledge of:
• ICH E6 (R3) Guideline
• 21 CFR Part 11 Electronic Records; Electronic Signatures
• 21 CFR Part 50 Protection of Human Subjects (Informed Consent)
• 21 CFR Part 312 Investigational New Drug Application
• 21 CFR Part 812 Investigational Device Exemptions
• Clinical Trials Regulation (CTR) (EU) No 536/2014
• Directive 2001/20/EC (Clinical Trial Directive)
• Directive 2005/28/EC (GCP Directive)
• Directive 2001/83/EC (Annex I)
• Organizational Agility: Strong analytical and problem-solving capabilities, the ability to work with limited supervision, and flexibility to manage a schedule involving up to 50% travel.

About CSL Behring

CSL Behring is a global biotherapeutics company committed to saving lives. We focus on meeting patients needs through advanced technologies, discovering, developing, and delivering innovative treatments for conditions across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Our three key scientific platforms&;plasma fractionation, recombinant protein technology, and cell and gene therapy&;support ongoing innovation and help us develop solutions that address unmet medical needs and enable patients to live fuller lives.

CSL Behring operates one of the worlds 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.