Senior GCP QA Auditor 30-50% Europe Travel

IQVIA Inc; Warszawa; Hybrid; PLN 168,000 - 312,000; Full time

Job summary

IQVIA Inc in Warsaw, Poland is seeking a Senior QA Auditor to plan and conduct independent GCP audits, assess regulatory compliance, and prepare reports for stakeholders. You will provide interpretation of regulations to project teams and support management in promoting compliance with guidelines and corporate policies.

Essential duties include leading multi-country audits, evaluating findings, and coordinating corrective actions while maintaining the eQMS.

Qualifications

• 5 years of experience in GCP environment, with 3 years in Quality Assurance Site Audit.
• Experience leading clinical trial Investigator site audits (7–10 per year).
• Willingness to travel 30–50% mainly in Europe.
• Knowledge of word-processing, spreadsheet, and database applications.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts to assess compliance with regulations, guidelines, and SOPs.
• Evaluate audit findings and prepare and distribute reports to staff, management and customers.
• Consult with project teams on regulations, guidelines, compliance, policies and procedures.
• Review and track CAPA, RCA, EC plans and close quality events arising from audits or inspections.
• Maintain the eQMS and support the audit lifecycle, including training of QA staff.

Job description

IQVIA Inc in Warsaw, Poland is seeking a Senior QA Auditor to plan and conduct independent GCP audits, assess regulatory compliance, and prepare reports for stakeholders. You will provide interpretation of regulations to project teams and support management in promoting compliance with guidelines and corporate policies.

Essential duties include leading multi-country audits, evaluating findings, and coordinating corrective actions while maintaining the eQMS.