GCP QA Auditor – Radiopharmaceuticals
Job in
Paramus, Bergen County, New Jersey, 07653, USA
Listed on 2026-02-07
Listing for:
Confidential Recruiting Partners
Full Time
position Listed on 2026-02-07
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
GCP QA Auditor (Clinical) – Radiopharmaceutical...
Our client is seeking a GCP Quality Assurance Auditor
to support global clinical development programs. This role ensures GXP compliance, leads internal and external audits, and partners closely with Clinical Operations, Safety/PVG, and Manufacturing teams. The ideal candidate brings strong GCP expertise and hands‑on experience auditing radiopharmaceutical programs.
Contract Duration: 6 months| W2
Work Model: 3 days onsite (Tue/Wed/Thu), 2 days remote
Work Schedule: Flexible hours between 7:30AM–5:00PM (8‑hour shift)
Travel: Up to 10% of domestic travel, as needed
Responsibilities:
- Plan and conduct global clinical process audits across all phases of clinical trials.
- Perform vendor audits (CROs, CMOs, investigator sites) with SMEs across IRT, EDC, and other clinical systems.
- Develop audit reports, track non‑conformances, and ensure timely CAPA follow‑up.
- Review and interpret clinical regulations and guidelines (FDA, EMA, ICH GCP)
- Partner with Clinical Sourcing, Supplier Quality, and Clinical Operations to oversee vendor compliance.
- Support inspection readiness activities and participate in regulatory agency inspections.
- Contribute to quality improvement initiatives and enhancements to the Quality Management System (QMS)
Qualifications/Must-Haves:
- 2+ years of Radiopharmaceutical experience.
- 5+ years of pharmaceutical industry experience.
- Experience auditing clinical systems such as IRT and EDC.
- 2+ years of Quality Assurance experience with strong GCP focus.
- Bachelor's degree in a scientific, healthcare, or related discipline.
- Proven experience conducting internal and external GXP audits (clinical development, safety/PVG)
- Strong understanding of GCP, FDA/EMA regulations, SOPs, QMS, and compliance documentation.
- Ability to collaborate with global clinical teams and manage multiple audit priorities.
Nice-to-Haves:
- RQAP‑GCP, CQA, or other QA/auditing certifications.
- Familiarity with radiopharmaceutical manufacturing or non‑clinical QA.
- Experience with audit management tools (e.g., Veeva Vault QMS, Master Control)
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