Senior Clinical QA Auditor — Lead Global GCP Audits

IQVIA; Indianapolis (IN); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking an experienced Quality Assurance Auditor to independently plan and conduct GCP audits across a diverse portfolio of clinical research programs. You will ensure regulatory compliance, provide interpretation of guidelines, and support corrective actions.

The role involves global collaboration, CAPA/RCA activities, and ongoing QA initiatives within IQVIA's quality organization. Willingness to travel 30-50% is required.

Qualifications

• Experience conducting clinical trial Investigator Site Audits.
• Travel 30-50%.
• 5 years in pharmaceutical or related area, with 3 years QA audits.
• Knowledge of regulatory environments and QA processes.
• Strong problem solving and negotiation skills.
• Ability to work independently.
• Excellent organizational and communication skills.
• Proficient with word-processing, spreadsheets, and databases.

Responsibilities

• Plan, schedule, conduct, report and close audit activities.
• Evaluate findings and prepare reports to stakeholders.
• Provide interpretation and consultation on regulations and procedures.
• Review investigations, CAPA and RCA plans and track closure.
• Maintain the electronic quality management system (eQMS) and support audit lifecycle.
• Lead, collaborate in, or support QA initiatives and process improvements.

Skills

GCP experience

Auditing

Quality Assurance

Communication

Project management

Education

Bachelor's Degree

Job description

IQVIA is seeking an experienced Quality Assurance Auditor to independently plan and conduct GCP audits across a diverse portfolio of clinical research programs. You will ensure regulatory compliance, provide interpretation of guidelines, and support corrective actions.

The role involves global collaboration, CAPA/RCA activities, and ongoing QA initiatives within IQVIA's quality organization. Willingness to travel 30-50% is required.