Auditor – GCP

CSL

CQA Auditor executing global audit plan for clinical trial compliance at CSL Behring. Conducting audits, reporting findings, and improving operational resilience.

Posted 5/27/2026full-timeKing of Prussia • Illinois, Pennsylvania • 🇺🇸 United StatesMid-LevelSeniorWebsite

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Hard Skills

clinical auditquality assurancedata integritycorrective and preventive actionsrisk managementGCP regulationsclinical trial phasesmonitoringregulatory frameworksaudit report development

Soft Skills

interpersonal skillsnegotiation skillsanalytical skillsproblem-solving skillscommunication skillsstakeholder collaborationindependent worktime managementmultinational team collaborationadaptability

Industry Keywords

GCPICH E6Contract Research OrganizationsInstitutional Review Boardsstandard operating proceduresclinical researchaudit conductnon-compliance trendsclinical development programsrisk-based solutions

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
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.
Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Requirements

What you’ll need

BS degree in a relevant biological science, science, or related discipline
Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% global travel.

Benefits

Comp & perks

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL