GCP QA Auditor Radiopharmaceuticals & Clinical Trials

Job Title: GCP Quality Assurance Auditor – Radiopharmaceuticals | Northern NJ

Location: Northern New Jersey (Hybrid: 3 days onsite, 2 days remote)

Job Description:
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites).

The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.

Key Responsibilities:

• Plan and perform global clinical process and vendor audits across all clinical trials
• Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
• Prepare detailed audit reports and manage related non-conformances
• Ensure compliance with GCP, FDA, EMA, and ICH regulations
• Support regulatory inspections and quality improvement initiatives
• Collaborate with clinical teams, QA, and vendor management

Qualifications:

• Bachelor's degree in a scientific, healthcare, or related discipline
• 5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
• Extensive GCP and safety/pharmacovigilance experience
• Proven experience in internal and external GXP audits
• Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
• Strong communication and cross-functional collaboration skills
• Up to 10% domestic travel

Why Join Us:

• Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
• Hybrid work schedule with flexible hours
• Opportunity for extension or full-time role