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.

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.

• 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.
  

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.