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