Lead Clinical QA Auditor: GCP Compliance & Audits

IQVIA Argentina; Wayne (NJ); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA seeks an experienced Quality Assurance Auditor to independently plan and conduct GCP clinical site audits across a diverse portfolio, assess regulatory compliance, and report findings to management and customers. You will lead the audit lifecycle and collaborate with global teams to drive quality improvements.

Requirements include 5 years in pharmaceutical/related areas, 3 years in QA audits, GCP experience, travel 30-50%, strong communication, problem solving, and the ability to manage

Qualifications

• Experience in clinical trial Investigator Site Audits.
• 5 years in pharma/related area with 3 years in QA audits.
• GCP experience and knowledge of QA processes.
• Strong communication, problem solving and risk analysis.
• Ability to manage multiple projects and work with cross-functional teams.

Responsibilities

• Plan, schedule, conduct, report and close audit activities.
• Evaluate findings and prepare reports for stakeholders.
• Provide consultation on regulations and QA status.
• Lead CAPA plans and follow-up to closure.
• Maintain eQMS and support QA initiatives.

Skills

GCP experience

Interpersonal skills

Problem solving

Negotiation skills

Independent work

Organization

Communication

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

IQVIA seeks an experienced Quality Assurance Auditor to independently plan and conduct GCP clinical site audits across a diverse portfolio, assess regulatory compliance, and report findings to management and customers. You will lead the audit lifecycle and collaborate with global teams to drive quality improvements.

Requirements include 5 years in pharmaceutical/related areas, 3 years in QA audits, GCP experience, travel 30-50%, strong communication, problem solving, and the ability to manage