GCP QA Auditor & Compliance Leader

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

Job summary

IQVIA in Indianapolis, IN seeks an experienced QA auditor to plan and conduct independent GCP audits across IQVIA contracts worldwide. You will prepare reports, advise project teams, and support management in regulatory compliance and process improvements.

The role requires 5+ years in pharma/quality, travel 30-50%, and strong analytical and interpersonal skills to guide CAPA and corrective actions.

Qualifications

• Bachelor's Degree preferred.
• Travel 30-50%.
• 5 years experience in pharmaceutical, technical, or related area, with 3 years in Quality.
• Assurance Audits; GCP experience.
• Experience in clinical trial investigator site audits.
• Experience in clinical study report/data management/biostatistics audits preferred.
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical R&D processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal, problem solving, risk analysis and negotiation skills.

Responsibilities

• Plan, schedule, conduct, report and close audits per IQVIA contracts.
• Evaluate audit findings and prepare reports for stakeholders.
• Provide interpretation of regulations, guidelines, and procedures to teams.
• Assist in corrective action plans and CAPA tracking.
• Review investigations, RCA, CAPA and EC plans and track closure.
• Maintain eQMS and support audit lifecycle activities.
• Lead or collaborate on QA initiatives and training.
• May manage quality issues and present educational programs.

Skills

GCP auditing

Quality Assurance

Regulatory compliance

Investigator site audits

Interpersonal skills

Analytical skills

Education

Bachelor's degree

Tools

Office software

eQMS

Word processing / spreadsheets / databases

Job description

IQVIA in Indianapolis, IN seeks an experienced QA auditor to plan and conduct independent GCP audits across IQVIA contracts worldwide. You will prepare reports, advise project teams, and support management in regulatory compliance and process improvements.

The role requires 5+ years in pharma/quality, travel 30-50%, and strong analytical and interpersonal skills to guide CAPA and corrective actions.