GCP Quality Assurance Auditor (Radiopharmaceuticals)
About The Position
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. 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.
Requirements
- 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
Nice To Haves
- Experience supporting regulatory inspections
- Exposure to global clinical teams and vendors
- GCP or Quality Auditor certification (preferred, not required)
- Must be willing and able to work 100% onsite in Paramus, NJ
- Monday–Friday onsite schedule
- Up to 10% travel
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
- 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
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What This Job Offers
Career Level
Mid Level
