Senior CAPA & Quality Assurance Lead – GCP

IQVIA; Madrid; Presencial; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

IQVIA in Madrid, Spain, seeks a seasoned Quality Assurance professional to lead CAPA management for significant quality issues and audit responses. You will assess investigations, conduct root-cause analysis, and implement corrective and preventive actions with strong regulatory alignment.

You will mentor CAPA teams, drive cross-functional improvements, and ensure documentation in eQMS while coordinating with audits and inspections. Strong leadership and GCP expertise are essential.

Formación

• Extensive knowledge of CAPA management, GCP guidelines and regulations for clinical trials.
• Experience in audit and inspection management and support.
• Root cause analysis and quality investigations.
• Ability to independently manage complex quality issues with minimal supervision.
• Experience driving CAPAs to closure.
• 7+ years of Quality Assurance in pharma/related with GCP in Clinical Trials.
• Background in science/healthcare and understanding of clinical trial processes.
• Strong leadership and organizational skills; ability to prioritize workload.
• Excellent problem-solving and mentoring abilities.
• Ability to handle multiple projects in a fast-paced environment.
• Strong communication with clients/vendors/employees.
• Proficient in Microsoft Office.

Responsabilidades

• Lead CAPA management team to ensure compliant, timely actions.
• Oversee CAPA activities for complex QIs and audits.
• Collaborate with cross-functional teams to close gaps.
• Ensure CAPAs are documented in eQMS and tracked.
• Identify risks and drive continuous CAPA improvements.
• Provide training on RCA and CAPA processes.
• Advise QA management on audit needs.
• Support external and internal audits/inspections.

Conocimientos

CAPA Management

GCP Guidelines

Audit & Inspection

Root Cause Analysis

Leadership

Problem Solving

Documentation

Educación

Bachelor's Degree

Herramientas

eQMS

Microsoft Office

Descripción del empleo

IQVIA in Madrid, Spain, seeks a seasoned Quality Assurance professional to lead CAPA management for significant quality issues and audit responses. You will assess investigations, conduct root-cause analysis, and implement corrective and preventive actions with strong regulatory alignment.

You will mentor CAPA teams, drive cross-functional improvements, and ensure documentation in eQMS while coordinating with audits and inspections. Strong leadership and GCP expertise are essential.