GCP Quality Assurance Auditor

Overview

Our client is seeking to add a GCP Quality Assurance Auditor to their team. This role focuses on ensuring GXP compliance with regulatory authorities, supporting quality management systems, and minimizing risk in a regulated pharmaceutical environment. The position will involve participating in internal and external GXP QA audit programs and supporting the GXP QA Director in clinical operations/non-clinical and manufacturing activities to manage CROs, CMOs, investigator sites, and other vendors to support clinical trials.

This on-site role is based in Northern New Jersey.

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits with SMEs (IRT, EDC, etc.) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute them to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP).
• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections.
• Participate in and support quality improvement projects.

• 5+ years of pharmaceutical experience
• 2+ years of Radiopharmaceutical and Quality Assurance experience
• BS degree in scientific, health care or related discipline
• Intensive GCP and safety background
• Experience with both internal and external process and systems audits
• Strong knowledge of development policies, procedures and standards (SOPs, QMS)
• Ability to work with global clinical teams in developing objectives for audits of clinical studies
• 10% traveling required