Senior GCP Auditor - Radiopharmaceuticals - Onsite, NJ

Job Description

Job Description

Our client is seeking a GCP Senior Auditor with radiopharmaceuticals experience to support global clinical development and pharmacovigilance audit programs. This role ensures GXP compliance, supports inspection readiness, and drives quality oversight across clinical operations, CROs, CMOs, investigator sites, and clinical vendors.

This opportunity is with a rapidly growing biopharmaceutical organization specializing in neurology and psychiatry therapies. The role requires strong GCP expertise, vendor audit experience, and the ability to operate in a highly regulated environment.

Onsite | No Visa Sponsorship | No Relocation Assistance

Contract Duration: 5 months

Responsibilities:

• Participate in quality improvement initiatives.
• Conduct vendor audits with SMEs (IRT, EDC, etc.)
• Develop audit reports and manage non‑conformances.
• Audit against FDA, EMA, ICH GCP, and internal SOPs/QMS.
• Support regulatory inspection preparation and participation.
• Perform risk‑based audits of clinical systems and processes.
• Collaborate with clinical sourcing, supplier quality, and clinical operations.
• Plan and conduct global clinical process audits and clinical vendor audits.
• Provide day‑to‑day QA support across clinical, non‑clinical, and manufacturing functions.

Qualifications/Must Haves:

• Ability to travel up to 10%.
• 5+ years of pharmaceutical industry experience.
• Extensive GCP and safety/pharmacovigilance background.
• Experience conducting internal and external GXP audits.
• Experience with radiopharmaceuticals and quality (must‑have)
• Bachelor's degree in a scientific, healthcare, or related discipline.
• Familiarity with IRT and EDC systems from an audit perspective.
• Strong understanding of SOPs, QMS, and global regulatory requirements.
• Experience auditing CROs, CMOs, investigator sites, and clinical vendors.
• Excellent communication, reporting, and stakeholder management skills.

Preferred Skills:

• Certified Quality Auditor (CQA) or similar credential.
• Experience in mid‑size or growing biopharma environments.
• Experience with QMS tools (e.g., Veeva Vault, MasterControl, TrackWise Digital)

Work Environment:

• Cross‑functional collaboration with QA, clinical operations, PVG, and external vendors.