GCP Clinical Audit Specialist

CSL; King of Prussia (PA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

CSL Behring in King of Prussia, PA is seeking an experienced GCP Auditor to join our R&D Quality audit program. You will execute the global audit plan, assess clinical investigator sites, CROs, and trial management processes, and identify findings that impact data integrity.

You will develop corrective actions with stakeholders, maintain up-to-date regulatory knowledge (ICH E6 and global requirements), and support SOP improvements to strengthen trial compliance and systemic quality across

Qualifications

• BS degree in a relevant biological science, science, or related discipline.
• 3+ years of Quality Assurance experience within a GCP-regulated environment.
• Experience in clinical audit and inspection management.
• Excellent interpersonal and negotiation skills with multinational teams.

Responsabilités

• Audit Execution: External audits of clinical sites, CROs, E-System providers, and IRBs/ECs.
• Reporting & Risk Categorization: Audit Reports with CAPA recommendations.
• Trend Analysis: Identify non-compliance trends and systemic risks.
• Continuous Improvement: Improve SOPs for audit conduct and risk-based solutions.
• Regulatory Knowledge: Maintain up-to-date global GCP regulations and trends.

Connaissances

GCP QA

Audit management

Communication skills

Regulatory knowledge

Travel readiness

Formation

BS degree in a relevant biological science

Outils

ICH E6 (R3)

21 CFR Part 11

21 CFR Part 50

21 CFR Part 312

21 CFR Part 812

Description du poste

CSL Behring in King of Prussia, PA is seeking an experienced GCP Auditor to join our R&D Quality audit program. You will execute the global audit plan, assess clinical investigator sites, CROs, and trial management processes, and identify findings that impact data integrity.

You will develop corrective actions with stakeholders, maintain up-to-date regulatory knowledge (ICH E6 and global requirements), and support SOP improvements to strengthen trial compliance and systemic quality across