GCP Quality Assurance Auditor (Radiopharmaceuticals)

Job Description
GCP Quality Assurance Auditor (Radiopharmaceuticals)

Paramus, NJ (Onsite) Contract Mid-Senior Level 1 Opening

Hourly Rate: $60/hour No Relocation Assistance No Visa Sponsorship

Travel: Up to 10%

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