GCP QA Auditor (Clinical) – Radiopharmaceuticals | Hybrid | Paramus, NJ

About the position

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 Responsibilities: 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) Qualifications/Must-Haves: 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. Nice-to-Haves: 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, MasterControl)

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