GCP Auditor; RadioPharmaceuticals and GCP Quality

JOB DESCRIPTION: The GCP Quality Assurance Auditor will report to the Director of GCP/PVG Quality Assurance and focus on ensuring GXP compliance with regulatory authorities, implementing the Company’s compliance directives, and supporting quality management systems to minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and participate in all GXP QA audit programs, including internal and external audits, and provide day‑to‑day support to the GXP QA Director in clinical operations, non‑clinical and manufacturing.

The Auditor will work with QA and cross‑functional teams, communicate with QA consultants, and maintain contact with external auditees, vendors, partners and affiliates. The role is based in Northern New Jersey and requires on‑site presence. The position performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance.

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits with various SMEs (IRT, EDC, etc.) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute them to appropriate stakeholders.
• Own and manage related clinical vendor non‑conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regulations, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections.
• Participate in and support quality improvement projects.

• 5+ years of pharmaceutical experience.
• 2+ years of Radio Pharmaceutical experience.
• 2+ years of GCP quality experience.
• BS degree in a scientific, health care or related discipline.
• Intensive GCP and safety background.
• Experience with both internal and external process and systems audits.
• Strong knowledge of development policies, procedures and standards (SOPs, QMS).
• Ability to work with global clinical teams in developing objectives for audits of clinical studies.
• 10% traveling required.