GCP Audit Specialist — Data Integrity & CAPA Pro

BioSpace; King of Prussia (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL Behring is seeking an experienced GCP Auditor to join our R&D Quality audit program in the United States. You will execute the global audit plan, assessing clinical investigator sites, external vendors, and internal trial management processes to ensure data integrity and regulatory compliance.

The role requires 3+ years of QA experience in a GCP environment, strong communication, and collaboration with multinational teams.

Qualifications

• BS degree in a relevant biological science, science, or related discipline.
• 3+ years of Quality Assurance experience within a GCP-regulated environment.
• Audit and inspection management experience in clinical research.
• Excellent interpersonal and negotiation skills for multinational teams.
• Working knowledge of ICH E6 (R3) and applicable CFR/CTR requirements.

Responsibilities

• Audit Execution: conduct external audits of sites, CROs, e-system providers and IRBs/ECs.
• Reporting & Risk Categorization: produce audit reports with CAPA recommendations.
• Trend Analysis: identify non-compliance trends and systemic risks in GCP.
• Continuous Improvement: improve SOPs and implement risk-based solutions.
• Regulatory Knowledge: stay current with global GCP regs and industry trends.

Skills

GCP auditing

Regulatory knowledge

Communication

Interpersonal skills

Education

BS in Biological Science or related

Job description

CSL Behring is seeking an experienced GCP Auditor to join our R&D Quality audit program in the United States. You will execute the global audit plan, assessing clinical investigator sites, external vendors, and internal trial management processes to ensure data integrity and regulatory compliance.

The role requires 3+ years of QA experience in a GCP environment, strong communication, and collaboration with multinational teams.