CAPA Excellence Lead — Quality Assurance & GCP

IQVIA; Warszawa; Presencial; PLN 168.000 - 312.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a CAPA-driven QA Lead to oversee corrective and preventive actions across significant quality issues, audits, and investigations. You will mentor the CAPA team, ensure robust root cause analysis, and drive compliance with GCP and sponsor requirements within an eQMS framework.

The role emphasizes risk identification, process improvement, and timely execution of actions. Strong leadership, collaboration, and mentoring are essential for success in a fast-paced environment.

Formación

• Bachelor’s Degree in a related field.
• 7 years Quality Assurance experience in pharma with GCP focus.
• Experience in CAPA management and audits/inspections.
• Root cause analysis and quality investigations.
• Ability to manage complex issues with minimal supervision.
• Strong leadership and mentoring capabilities.

Responsabilidades

• Lead and mentor the CAPA management team to drive improvements and ensure regulatory alignment.
• Lead CAPA activities for complex QIs and sponsor audits/inspections with robust RCAs and actions.
• Collaborate with cross-functional stakeholders to close process gaps and ensure QA compliance.
• Ensure CAPA reporting in the electronic quality management system (eQMS).
• Monitor corrective actions and effectiveness checks within required timelines.
• Promote proactive process improvement and risk-based CAPA optimization.
• Foster teamwork and clear communication among all stakeholders.
• Provide training on RCA, CAPA, good documentation practices, and compliance.
• Develop and improve governing procedures and work instructions.
• Advise Quality Assurance on system audit needs and readiness.
• Support external and internal audits and inspections as needed.

Conocimientos

CAPA management

GCP guidelines

Root cause analysis

Leadership

Training & mentoring

Problem solving

Excel

eQMS

Educación

Bachelor’s Degree

Herramientas

Microsoft Word

Microsoft Excel

eQMS

Descripción del empleo

IQVIA is seeking a CAPA-driven QA Lead to oversee corrective and preventive actions across significant quality issues, audits, and investigations. You will mentor the CAPA team, ensure robust root cause analysis, and drive compliance with GCP and sponsor requirements within an eQMS framework.

The role emphasizes risk identification, process improvement, and timely execution of actions. Strong leadership, collaboration, and mentoring are essential for success in a fast-paced environment.