Senior QA Auditor — Global GCP Compliance & Audits

IQVIA; Durham (NC); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking a QA Audit professional in Durham, NC to plan and conduct independent clinical (GCP) audits. The role involves reporting findings to supervisors and customers, interpreting regulations, and supporting management in QA initiatives.

The candidate will review investigations, RCA, CAPA plans, and track closure, while maintaining the eQMS and guiding QA activities across multiple projects. Travel 30-50% is expected.

Qualifications

• Bachelor's degree preferred; 5 years in pharma/related area with 3 years in Quality.
• Willingness to travel 30-50%.
• Experience in GCP audits and clinical trial audits.
• Knowledge of QA processes and regulatory environments.
• Strong interpersonal, negotiation, and training skills.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate findings and prepare reports for operations, management and customers.
• Provide interpretation of regulations, guidelines, policies, and procedures.
• Support customers and monitors in interpretation of audit observations and corrective action plans.
• Review and approve RCA, CAPA and EC plans; track to closure for quality events.
• Maintain eQMS and support audit lifecycle activities.
• Lead or support QA initiatives and training for staff.
• May present educational programs to operational staff on compliance.

Skills

GCP audits

Risk analysis

Project management

Communication

Team collaboration

Independent work

Education

Bachelor's degree

Tools

MS Word

Excel

Databases

Job description

IQVIA is seeking a QA Audit professional in Durham, NC to plan and conduct independent clinical (GCP) audits. The role involves reporting findings to supervisors and customers, interpreting regulations, and supporting management in QA initiatives.

The candidate will review investigations, RCA, CAPA plans, and track closure, while maintaining the eQMS and guiding QA activities across multiple projects. Travel 30-50% is expected.