Senior QA Auditor - GCP Audits (GCP)

Location: Madrid, Spain; travel 30–50%, mainly in Europe.

Company

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

What you will do

• Plan, schedule, conduct, report, and close independent clinical Good Clinical Practice audits across countries involved in IQVIA contracts.
• Assess compliance with regulations, guidelines, customer requirements, IQVIA standard operating procedures, and project-specific instructions.
• Evaluate audit findings and prepare reports for operations staff, management, supervisors, and customers.
• Advise project teams, customers, and monitors on regulations, audit observations, compliance status, and corrective action plans.
• Review and approve investigations, root cause analyses, Corrective and Preventive Action plans, and effectiveness checks through closure.
• Maintain the electronic quality management system, support quality initiatives, training, inspections, and continuous process improvements.

Requirements

• Certification to conduct audits in Italy under the Italian Ministry of Health Decree dated 15 November 2011.
• At least 5 years of experience in pharmaceutical, technical, or related fields, including 3 years in Quality Assurance Audits.
• Experience conducting clinical trial investigator site audits.
• Extensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance procedures.
• Strong problem-solving, risk analysis, negotiation, communication, organization, training, and interpersonal skills.
• Ability to work independently, manage multiple projects, and maintain effective relationships with colleagues, managers, and clients.

Nice to have

• Experience conducting clinical study report, data management, or clinical trial audits.
• Knowledge of word-processing, spreadsheet, and database applications.

Culture & Benefits

• Full-time employment in a global healthcare and life sciences organization.
• Opportunity to collaborate with operational teams, management, customers, and clinical research stakeholders.
• Work involving international audits and travel primarily across Europe.
• Environment focused on integrity, diversity, inclusion, belonging, and improving patient outcomes.