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