Remote Senior QA Auditor — CAPA & Audit Lead

ICON Clinical Research; Warszawa; Remote; PLN 341,000 - 568,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks support

Job summary

ICON plc is seeking a Senior Auditor in Quality Assurance for a remote role across Poland, Bulgaria, or South Africa. The candidate will lead external/client audits, manage CAPAs, and coordinate with cross‑functional teams to ensure regulatory compliance and audit readiness.

Ideal candidates have a clinical background, strong CAPA/root cause skills, and experience with GCP guidelines. Occasional travel may be required to support audits and inspections.

Qualifications

• BSc degree in a relevant field is required.
• Experience with CAPA management and hosting external audits is essential.
• Knowledge of GCP guidelines and regulatory expectations is important.
• Ability to review clinical data/records and communicate effectively.
• Willingness to travel occasionally and manage multiple tasks.
• Experience in quality systems and CAPA processes is beneficial.

Responsibilities

• Lead and support external/client audits of ICON, including scheduling, preparation and hosting.
• Lead CAPA management for external/client audits, ensuring responses meet SOP requirements.
• Collaborate with teams to develop, review, and finalize audit responses and corrective actions.
• Lead quality issue investigations and root cause analyses to identify systemic issues and drive CAPA actions.
• Oversee CAPA lifecycle, tracking, escalation and timely closure.
• Monitor CAPA effectiveness checks and ensure long-term resolution.
• Provide guidance on CAPA development, root cause analysis, and regulatory expectations.
• Analyze CAPA trends and quality metrics to drive improvements across quality systems.
• Collaborate with stakeholders to strengthen quality culture and ensure consistent application.

Skills

CAPA management

Audit hosting

Root cause analysis

Regulatory knowledge

Clinical data review

Communication skills

Project management

Education

BSc Degree

Job description

ICON plc is seeking a Senior Auditor in Quality Assurance for a remote role across Poland, Bulgaria, or South Africa. The candidate will lead external/client audits, manage CAPAs, and coordinate with cross‑functional teams to ensure regulatory compliance and audit readiness.

Ideal candidates have a clinical background, strong CAPA/root cause skills, and experience with GCP guidelines. Occasional travel may be required to support audits and inspections.