GCP Senior Auditor

GCP Senior Auditor

A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance programs across global clinical development and safety operations. This role is ideal for a QA professional with deep GCP expertise and a strong understanding of pharmaceutical regulations, vendor oversight, and quality management systems.

This is a hybrid position based in Paramus, NJ , requiring regular onsite presence.

Position Overview

The GCP Senior Auditor plays a key role in ensuring compliance with regulatory requirements, internal SOPs, and quality standards across clinical research and pharmacovigilance functions. Reporting to the Director of GCP/PVG Quality Assurance, this position will plan and execute internal and external audits, oversee vendor compliance, and contribute to continuous improvement initiatives within the company’s GxP Quality System.

Key Responsibilities

• Plan and conduct global clinical process and vendor audits across all clinical trials.

• Perform risk-based audits of specific GCP processes and systems.

• Collaborate with SMEs (e.g., IRT, EDC) to assess vendor performance and compliance.

• Develop and deliver detailed audit reports and track CAPAs and non-conformances.

• Ensure adherence to FDA, ICH GCP, and other global regulatory guidelines.

• Support the preparation and coordination of regulatory agency inspections .

• Partner with cross-functional teams in Clinical Operations, Pharmacovigilance, and Manufacturing to strengthen audit readiness.

• Participate in quality improvement projects and contribute to SOP and QMS enhancements.

Requirements

Required Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline.

• 5+ years of pharmaceutical industry experience with a focus on GCP auditing.

• Demonstrated expertise in clinical and vendor audit management .

• Strong understanding of GxP compliance , SOPs , and QMS frameworks .

• Proven ability to lead audits independently and collaborate across global teams.

• Excellent knowledge of FDA regulations , ICH-GCP , and related standards.

• Ability to travel up to 10% domestically and internationally.

Preferred Experience & Skills

• Experience supporting regulatory inspections and audit CAPA processes.

• Knowledge of Safety/Pharmacovigilance and Clinical Development operations.

• Strong written and verbal communication skills with executive-level presence.

• Ability to manage multiple audits and priorities in a fast-paced environment.