Senior GCP QA Auditor - Global Compliance & Audits

IQVIA Inc; Województwo mazowieckie; On-site; PLN 168,000 - 312,000; Full time

Job summary

IQVIA Inc. invites qualified professionals to join our clinical audit team in Poland. The role focuses on planning and conducting independent GCP audits across IQVIA contracts, with emphasis on regulatory compliance, report generation, and stakeholder consultation.

You will support QA initiatives, training, and potential regulatory inspections. The ideal candidate has 5 years in GCP environments, 3 years in QA Site Audits, and strong communication and problem-solving abilities.

Qualifications

• 5 years of experience in GCP environments.
• 3 years in Quality Assurance Site Audit is a must.
• Experience leading clinical trial Investigator site audits (7–10 per year) is required.
• Nice to have a certification to conduct audits in Italy per Italian Decree 2011.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical R&D processes and regulatory environments.
• Strong interpersonal, problem solving, and negotiation skills.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate audit findings and prepare distribution of reports to staff and customers.
• Provide interpretation and consultation on regulations, guidelines, policies, and procedures.
• Lead QA initiatives/projects and support audit lifecycle improvements.
• May train new Quality Assurance staff and assist in regulatory facility inspections.

Skills

GCP experience

QA site audit

Audit leadership

Regulatory interpretation

Interpersonal skills

Training capability

Organizational skills

Independent work

Multi-project management

Tools

Word processing tools

Spreadsheet tools

Database applications

Job description

IQVIA Inc. invites qualified professionals to join our clinical audit team in Poland. The role focuses on planning and conducting independent GCP audits across IQVIA contracts, with emphasis on regulatory compliance, report generation, and stakeholder consultation.

You will support QA initiatives, training, and potential regulatory inspections. The ideal candidate has 5 years in GCP environments, 3 years in QA Site Audits, and strong communication and problem-solving abilities.