Now Hiring: GCP Quality Assurance Auditor (Radiopharmaceuticals & GCP Quality)
Location: Paramus, NJ
Job Type: Contract – 6 Months
Work Arrangement: Hybrid (3 Days Onsite / 2 Days Remote)
Travel: Up to 10%

Position Overview
We are seeking an experienced GCP Quality Assurance Auditor to support a rapidly growing biopharmaceutical organization specializing in Neurology and Psychiatry therapies. This role focuses on ensuring GXP compliance, supporting quality systems, and executing internal and external audit programs across Clinical Development and Safety Pharmacovigilance.

Key Responsibilities

• Plan and conduct global clinical process and vendor audits
• Perform risk-based audits of clinical systems and processes
• Conduct vendor audits in collaboration with SMEs (IRT, EDC, etc.)
• Develop audit reports and communicate findings to stakeholders
• Manage vendor non-conformances and corrective actions
• Audit compliance with FDA regulations and GCP guidelines
• Support regulatory inspections and audit readiness initiatives
• Participate in quality improvement projects

Must-Have Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline
• 5+ years of pharmaceutical industry experience
• 2+ years of Radiopharmaceuticals experience
• 2+ years of GCP Quality Assurance experience
• Strong GCP and safety background
• Experience conducting internal and external GXP audits
• Strong knowledge of SOPs, QMS, and regulatory frameworks
• Working knowledge of FDA regulations

Preferred Experience

• Experience auditing CROs, CMOs, investigator sites, and vendors
• Familiarity with clinical systems (IRT, EDC, etc.)
• Quality/auditing certifications (RQAP-GCP, CQA)

Additional Information

• Hybrid schedule: onsite Tuesday, Wednesday, and Thursday each week; remote Monday and Friday
• Flexible hours within 7:30 AM – 5:00 PM (8-hour shift)
• 10% travel listed, but not likely; if needed, it will be domestic only
• This is a 6-month contract role with potential to extend and/or convert to full-time for the right fit