GCP Quality Assurance Auditor (Radiopharmaceuticals)

GCP Quality Assurance Auditor (Radiopharmaceuticals)

A growing biopharmaceutical organization is seeking a GCP Quality Assurance Auditor to support global GXP compliance across clinical development, safety/pharmacovigilance, and vendor oversight. This role is ideal for an experienced QA professional with deep GCP expertise and prior experience in Radiopharmaceuticals .

This is a 100% onsite role based in Paramus, NJ, supporting a regulated clinical environment.

Position Overview

The GCP Quality Assurance Auditor will support the GCP/PVG Quality function by planning, executing, and managing internal and external GXP audits . This role partners closely with Clinical Operations, Non-Clinical, Manufacturing, CROs, CMOs, investigator sites, and vendors to ensure compliance with global regulatory requirements and internal quality systems.

Key Responsibilities

• Plan and conduct global clinical process and vendor audits across all clinical trials

• Perform risk-based audits of clinical systems, processes, and vendors

• Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)

• Develop, finalize, and distribute audit reports to key stakeholders

• Own and manage audit findings, CAPAs, and non-conformances

• Audit compliance with GCP, FDA regulations, ICH guidelines , and internal SOPs

• Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight

• Support regulatory agency inspections and inspection readiness activities

• Contribute to continuous quality improvement initiatives

Requirements

Key Responsibilities

• Plan and conduct global clinical process and vendor audits across all clinical trials

• Perform risk-based audits of clinical systems, processes, and vendors

• Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)

• Develop, finalize, and distribute audit reports to key stakeholders

• Own and manage audit findings, CAPAs, and non-conformances

• Audit compliance with GCP, FDA regulations, ICH guidelines , and internal SOPs

• Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight

• Support regulatory agency inspections and inspection readiness activities

• Contribute to continuous quality improvement initiatives

Required Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline

• 5+ years of pharmaceutical industry experience

• 2+ years of experience in Radiopharmaceuticals

• 2+ years of Quality Assurance experience

• Extensive hands-on GCP auditing experience

• Proven experience conducting internal and external GXP audits , including:

  • Clinical Development

  • Safety / Pharmacovigilance

• Strong working knowledge of FDA, EMA, ICH GCP , and global regulatory requirements

• Experience auditing clinical systems such as IRT and EDC

• Familiarity with QMS, SOPs, and compliance documentation

Preferred Qualifications

• Experience supporting regulatory inspections

• Exposure to global clinical teams and vendors

• GCP or Quality Auditor certification (preferred, not required)

Work Requirements

• Must be willing and able to work 100% onsite in Paramus, NJ

• Monday–Friday onsite schedule

• Up to 10% travel