GCP Quality Assurance Auditor – Radiopharmaceuticals

GCP Quality Assurance Auditor – Radiopharmaceuticals

Our client is seeking an experienced GCP Quality Assurance Auditor to play a key role in ensuring GXP compliance across global clinical programs, with a specialized focus on radiopharmaceutical development. This role supports clinical operations, non‑clinical functions, and manufacturing partners by conducting internal and external audits, managing vendor oversight, and supporting regulatory inspection readiness.

You will work closely with cross‑functional teams, CROs, CMOs, investigator sites, and clinical vendors to ensure high‑quality execution of clinical trials in a regulated pharmaceutical environment.

Contract Duration: 6 months (potential to extend or convert based on performance and business needs) | W2

Work Model: 3 days onsite (Tue/Wed/Thu), 2 days remote (Mon/Fri)

Work Schedule: Flexible hours between 7:30AM–5:00PM (8‑hour shift)

Travel: Up to 10% of domestic travel, as needed

Requirements:

• Plan and conduct global clinical process audits and clinical vendor audits across all phases of clinical trials.
• Perform risk‑based audits of specific clinical processes and systems (e.g., IRT, EDC)
• Assess vendor compliance and manage related non‑conformances through closure.
• Prepare clear, comprehensive audit reports and communicate findings to stakeholders.
• Review and interpret applicable regulations and guidelines (FDA, ICH GCP, etc.)
• Partner with clinical sourcing, supplier quality, and clinical operations to manage vendor performance.
• Support preparation, coordination, and participation in regulatory agency inspections.
• Contribute to quality improvement initiatives and continuous enhancement of the QMS.

Qualifications/Must-Haves:

• 2+ years of experience in radiopharmaceuticals.
• 5+ years of experience in the pharmaceutical industry.
• Bachelor's degree in a scientific, healthcare, or related discipline.
• Experience auditing CROs, CMOs, investigator sites, and clinical vendors.
• Ability to collaborate with global clinical teams and SMEs during audits.
• Strong communication, documentation, and stakeholder‑management skills.
• 2+ years of GCP Quality Assurance experience, including internal and external audits.
• Strong understanding of GXP regulations, FDA requirements, SOPs, and QMS frameworks.