GCP Quality Assurance Auditor

Position Summary

We are seeking an experienced GCP Quality Assurance Auditor to support quality and compliance initiatives within a regulated biopharmaceutical environment. This role focuses on ensuring GxP compliance with global regulatory requirements, strengthening quality management systems (QMS), and supporting audit programs across clinical development, safety pharmacovigilance, and manufacturing operations.

The ideal candidate will bring strong Good Clinical Practice (GCP) experience, along with expertise in radiopharmaceutical environments and clinical vendor oversight. This position collaborates closely with cross‑functional teams, CROs, CMOs, investigator sites, and external partners to ensure audit readiness and minimize compliance risk.

This is a hybrid role requiring onsite work Tuesday through Thursday each week.

• Plan and conduct global clinical process audits across multiple clinical trials
• Perform risk‑based audits of clinical systems and processes
• Conduct internal and external GxP audits including:
  • Clinical vendors
  • Investigator sites
  • CROs and CMOs
• Review and audit compliance with regulatory standards including U.S. Food and Drug Administration (FDA) regulations and ICH‑GCP guidelines
• Support regulatory inspection readiness activities

• Perform vendor audits alongside subject matter experts (e.g., IRT, EDC platforms)
• Manage vendor audit findings and non‑conformances through resolution
• Collaborate with clinical sourcing, supplier quality, and clinical operations teams
• Support oversight of global vendors and clinical partners

• Develop and distribute audit reports to key stakeholders
• Support continuous improvement initiatives within the Quality Management System (QMS)
• Assist in developing audit strategies aligned with risk‑based approaches
• Work cross‑functionally to ensure adherence to SOPs, policies, and regulatory standards

• Bachelor’s degree in a scientific, healthcare, or related discipline
• Minimum 5+ years of experience in the pharmaceutical industry
• Minimum 2+ years of radiopharmaceutical experience
• Minimum 2+ years of GCP Quality Assurance experience
• Strong working knowledge of:
  • GCP regulations and clinical trial compliance
  • Safety and pharmacovigilance processes
  • Quality systems (SOPs, QMS frameworks)
• Experience performing both internal and external audits
• Ability to collaborate across global clinical teams

• Experience auditing clinical systems such as IRT and EDC platforms
• Experience supporting regulatory inspections
• Strong background in clinical development and safety pharmacovigilance audit programs

• Hybrid schedule:
  • Onsite:
    Tuesday, Wednesday, Thursday
  • Remote:
    Monday and Friday
• Flexible working hours between 7:30 AM and 5:00 PM (8‑hour shift)
• Office‑based environment with collaboration across cross‑functional teams

• Contract role initially approved for 6 months
• Strong potential for extension or full‑time conversion based on performance and business needs
• Travel requirement listed at approximately 10%, though travel is expected to be minimal and domestic only

If you are a detail‑driven QA professional with strong GCP auditing experience and a background in regulated pharmaceutical environments, we encourage you to apply.

Skills:

edc, safety background, gcp, gxp, auditing, irt, fda, compliance, clinical operations, clinical development, quality assurance, cmos, qms, radiopharmaceuticals, pharmacovigilance