GCP QA Auditor; Clinical – Radiopharmaceuticals | Hybrid | Paramus, NJ

Overview

Our client is seeking a GCP Quality Assurance Auditor to support global clinical development programs. This role ensures GXP compliance, leads internal and external audits, and partners closely with Clinical Operations, Safety/PVG, and Manufacturing teams. The ideal candidate brings strong GCP expertise and hands‑on experience auditing radiopharmaceutical programs.

Hybrid | No Visa Sponsorship | No Relocation Assistance

Contract Duration: 6 months | W2

Work Model: 3 days onsite (Tue/Wed/Thu), 2 days remote

Work Schedule: Flexible hours between 7:30AM–5:00PM (8‑hour shift)

Travel: Up to 10% of domestic travel, as needed

• Plan and conduct global clinical process audits across all phases of clinical trials.
• Perform vendor audits (CROs, CMOs, investigator sites) with SMEs across IRT, EDC, and other clinical systems.
• Develop audit reports, track non‑conformances, and ensure timely CAPA follow‑up.
• Review and interpret clinical regulations and guidelines (FDA, EMA, ICH GCP)
• Partner with Clinical Sourcing, Supplier Quality, and Clinical Operations to oversee vendor compliance.
• Support inspection readiness activities and participate in regulatory agency inspections.
• Contribute to quality improvement initiatives and enhancements to the Quality Management System (QMS)

• 2+ years of Radiopharmaceutical experience.
• 5+ years of pharmaceutical industry experience.
• Experience auditing clinical systems such as IRT and EDC.
• 2+ years of Quality Assurance experience with strong GCP focus.
• Bachelor's degree in a scientific, healthcare, or related discipline.
• Proven experience conducting internal and external GXP audits (clinical development, safety/PVG)
• Strong understanding of GCP, FDA/EMA regulations, SOPs, QMS, and compliance documentation.
• Ability to collaborate with global clinical teams and manage multiple audit priorities.

• RQAP‑GCP, CQA, or other QA/auditing certifications.
• Familiarity with radiopharmaceutical manufacturing or non‑clinical QA.
• Experience with audit management tools (e.g., Veeva Vault QMS, Master Control)