Senior QA Auditor – GCP Audits

IQVIA

Senior QA Auditor conducting GCP audits to assess compliance with clinical regulations at IQVIA. Responsible for audit activities, reporting findings and supporting compliance initiatives across Europe.

Posted 7/2/2026full-timeMadrid • 🇪🇸 SpainSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance practices. Proficient in conducting clinical audits, managing compliance, and providing training and consultation to ensure adherence to regulations and guidelines.

Highest-signal resume keywords

Clinical Audit ConductQuality Assurance ProcessesRegulatory ComplianceRoot Cause Analysis (RCA)Corrective Action Prevention (CAPA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial AuditsQuality Management System (eQMS)Risk AnalysisNegotiation SkillsReport PreparationProcess ImprovementRegulatory Guidelines InterpretationTraining CapabilitiesProject ManagementCompliance Assessment

Soft Skills

Interpersonal SkillsProblem SolvingEffective CommunicationTeam OrientationOrganizational Skills

Tools & Technologies

Word-Processing ApplicationsSpreadsheet ApplicationsDatabase Applications

Certifications & Qualifications

Audit Certification in Italy

Industry Keywords

Good Clinical Practice (GCP)Pharmaceutical IndustryQuality AssuranceRegulatory EnvironmentContinuous Process Improvement

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures.
Prepare and distribute reports of findings to supervisor, operations staff, management, and customers.
Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
Lead/collaborate/support in QA initiatives/projects for quality, process improvements.
Assist in training of new Quality Assurance staff.
May be required to manage Quality Issues.
May present educational programs and provide guidance to operational staff on compliance procedures.
May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

Requirements

What you’ll need

5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
Experienced in the conduct of clinical trial Investigator site audits.
Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Knowledge of quality assurance processes and procedures.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
Strong training capabilities.
Effective organization, communication, and team orientation skills.
Ability to initiate assigned tasks and to work independently.
Ability to manage multiple projects.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Benefits

Comp & perks

Health insurance
Professional development opportunities