Senior Quality Auditor, CAPA Centre of Excellence (GCP)

Location: Madrid, Spain

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead and mentor the CAPA management team, supporting consistent quality, compliance, and process improvement.
• Manage CAPA activities for complex quality issues, audits, and inspections, including investigations, root cause analysis, corrective and preventive actions, and effectiveness checks.
• Collaborate with cross-functional stakeholders to identify process gaps, risks, and improvement opportunities related to GCP and quality processes.
• Ensure CAPA documentation, reporting, tracking, and closure in the electronic quality management system.
• Develop training, guidance, procedures, templates, and work instructions for CAPA management, root cause analysis, and compliance.
• Support internal and external audits and inspections while maintaining inspection readiness.

Requirements

• Bachelor’s degree in science, healthcare, or a relevant discipline.
• Extensive knowledge of CAPA management, GCP guidelines, and clinical-trial regulations.
• Seven years of Quality Assurance experience in pharmaceuticals, technical, or related environments, with a focus on GCP and clinical trials.
• Experience with audit and inspection management, quality investigations, root cause analysis, and driving CAPAs to closure.
• Ability to independently manage complex quality issues, prioritize multiple projects, and work effectively in a changing environment.
• Strong leadership, communication, training, mentoring, problem-solving, and organizational skills; proficiency in Microsoft Office.

Culture & Benefits

• Work in a global clinical research and healthcare intelligence organization.
• Collaborate with cross-functional stakeholders, clients, vendors, and employees.
• Contribute to a culture of integrity, diversity, inclusion, belonging, and continuous improvement.