European QA Auditor – Regulatory Compliance & Audits

Lateral; Madrid; On-site; EUR 65,000 - 90,000; Full time

Job summary

IQVIA seeks an experienced QA Auditor to plan and conduct independent clinical (GCP) audits across multiple European countries. You will prepare reports, interpret regulations, and support management in promoting compliance to regulatory guidelines and corporate policies.

The role requires strong interpersonal skills, extensive QA experience in pharmaceutical settings, and the ability to work independently while managing multiple projects.

Qualifications

• 5 years experience in pharmaceutical, technical, or related area, with QA audits.
• Experience in conducting clinical trial Investigator site audits is required or preferred.
• Knowledge of regulations, guidelines and corporate policies.
• Strong interpersonal, communication, and negotiation skills.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across Europe to assess compliance with regulations and IQVIA SOPs.
• Evaluate audit findings and prepare reports to operations staff, management and customers.
• Provide interpretation and consultation on regulations, guidelines, compliance status, and procedures.
• Lead QA initiatives/projects and assist in training new QA staff.
• May conduct pre-inspection visits and host audits/inspections, supporting regulatory facility inspections as needed.

Skills

Audit planning

Regulatory compliance

Investigations

Risk analysis

Training

Cross-functional collaboration

Root Cause Analysis

Tools

eQMS

Job description

IQVIA seeks an experienced QA Auditor to plan and conduct independent clinical (GCP) audits across multiple European countries. You will prepare reports, interpret regulations, and support management in promoting compliance to regulatory guidelines and corporate policies.

The role requires strong interpersonal skills, extensive QA experience in pharmaceutical settings, and the ability to work independently while managing multiple projects.