Senior Quality Auditor, CAPA Centre of Excellence

Jobtailor; Madrid; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA Madrid-based quality assurance lead role focusing on CAPA management for clinical trials. Lead CAPA team, oversee investigations, root cause analyses and corrective actions, ensure eQMS reporting and inspection readiness.

Collaborate across functions, mentor staff, support audits, promote continuous improvement, and provide training on RCA, CAPA and compliance.

Formación

• Bachelor's Degree and extensive knowledge of CAPA Management, GCP guidelines and regulations for clinical trials.
• Prior experience in audit and inspection management/support.
• Root cause analysis and quality investigations.
• Ability to independently manage complex quality issues with minimal supervision.
• Experience reviewing and driving CAPAs to closure.

Responsabilidades

• Lead CAPA management for significant quality issues, audits and responses.
• Assess investigations, root cause analyses, CAPA actions and effectiveness checks.
• Provide management with quality insights, risk identification and mitigation.
• Oversee QA oversight of quality issues, audit responses, training and staff.
• Collaborate with cross-functional stakeholders to identify process gaps and improvements.
• Ensure CAPA reporting and documentation in the eQMS.
• Promote continuous process improvement by identifying risks and trends.
• Develop training and guidance on RCA, CAPA and compliance.
• Develop procedures, templates and work instructions.
• Support IQVIA audits and inspections and maintain inspection readiness.
• Lead team management activities.

Conocimientos

CAPA Management

GCP Guidelines

Root Cause Analysis

Quality Assurance

Audit Management

Leadership

Problem-Solving

Effective Communication

Training Development

Documentation

Educación

Bachelor's Degree

Herramientas

eQMS

Microsoft Office

Descripción del empleo

Lead and support effective corrective and preventive action (CAPA) management for significant quality issues, audits and inspection responses
Assess and review investigations, root cause analyses, corrective and preventative actions, and effectiveness checks
Provide management with quality insights, analyses, compliance assessments, risk identification and mitigation, and improvement initiatives
Manage quality assurance oversight of quality issues, audit responses, assignments, training and staff
Lead and mentor CAPA management team members
Collaborate with cross-functional stakeholders to identify process gaps and improvement areas
Ensure CAPA reporting and documentation in the electronic quality management system (eQMS)
Promote continuous process improvement by identifying risks and trends and optimizing CAPA systems and processes
Develop and provide training and guidance on RCA, CAPA management, execution, documentation practices and compliance
Develop and improve procedures, templates and work instructions
Advise Quality Assurance management on system audit needs
Support external and internal IQVIA audits and inspections and maintain inspection readiness
Lead team management activities

Requirements

• Bachelor's Degree
• Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials
• Prior experience in audit and inspection management/support
• Root cause analysis and quality investigations
• Ability to independently manage complex quality issues with minimal supervision
• Experience reviewing and driving CAPAs to closure
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials
• Background in science, healthcare and/or another relevant discipline and detailed understanding of the clinical trial process and GCP guidelines
• Strong leadership and organizational skills for prioritizing workload and responsibilities
• Excellent problem-solving and root cause analysis skills
• Excellent training and mentoring capabilities
• Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment
• Ability to speak effectively one-to-one and in group settings with clients, vendors and employees
• Proficiency in Microsoft Office applications, including Word and Excel

Core Competencies

Demonstrates extensive knowledge of CAPA Management and GCP guidelines, with a strong background in quality assurance within clinical trials. Capable of leading teams, managing complex quality issues, and promoting continuous process improvement through effective training and mentoring.

Highest-signal resume keywords

• CAPA Management
• GCP Guidelines
• Root Cause Analysis
• Quality Assurance Experience
• Audit Management

Hard Skills

• Corrective And Preventive Action (CAPA)
• Root Cause Analysis
• Quality Investigations
• Quality Management System (QMS)
• Compliance Assessments
• Risk Identification
• Process Improvement
• Training Development
• Documentation Practices
• Clinical Trial Process

Soft Skills

• Leadership
• Organizational Skills
• Problem-Solving
• Mentoring
• Effective Communication

Industry Keywords

• Pharmaceutical
• Clinical Trials
• GCP Compliance
• Audit Readiness
• Inspection Management

Tools & Technologies

• Electronic Quality Management System (eQMS)
• Microsoft Office