Senior CAPA & Quality Auditor – GCP Specialist

Dekra España; Madrid; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Sr. Quality Auditor to lead CAPA management across multiple sites, ensuring strong root cause analysis, effective corrective actions, and robust regulatory compliance. You will oversee audits, provide expert guidance, and drive continuous quality improvements within the CAPA framework.

The role requires extensive GCP knowledge, prior QA audit experience, and proven leadership in fast-paced environments. Travel across Europe may be required as part of audits and inspections.

Formación

• Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for clinical trials.
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area with focus on GCP.
• Experience in audit and inspection management/support.
• Ability to lead and mentor CAPA teams.
• Strong root cause analysis and problem solving skills.

Responsabilidades

• Lead and mentor CAPA management team to drive improvement and compliance.
• Oversee CAPA activities for complex QIs and sponsor audits.
• Collaborate with cross-functional stakeholders to close process gaps.
• Ensure proper reporting in eQMS and timely CAPA closure.

Conocimientos

CAPA Management

GCP guidelines

Root cause analysis

Quality investigations

Leadership

Audit & inspection

Excel

Communication

Educación

Bachelor's Degree

Herramientas

eQMS

Descripción del empleo

IQVIA is seeking a Sr. Quality Auditor to lead CAPA management across multiple sites, ensuring strong root cause analysis, effective corrective actions, and robust regulatory compliance. You will oversee audits, provide expert guidance, and drive continuous quality improvements within the CAPA framework.

The role requires extensive GCP knowledge, prior QA audit experience, and proven leadership in fast-paced environments. Travel across Europe may be required as part of audits and inspections.