Senior QA Auditor - GCP Audits

Overview

As a Quality Assurance Auditor, you will plan and conduct independent GCP audits across IQVIA contracts in Europe to verify regulatory and procedural compliance. You will produce findings reports for stakeholders and help customers interpret regulations and policies. You will support continuous process improvements, maintain the eQMS, and lead QA initiatives, including training staff and guiding corrective actions. This role blends audit execution with advisory support to project teams and customers, contributing to reliable, compliant clinical research operations. You will operate in a fast-paced, cross-functional environment with travel to sites across Europe, starting from Milan.

Retribuzione / Benefits

• health and welfare benefits
• potential bonuses or incentive plans
• career development and training opportunities
• travel opportunities across Europe
• structured onboarding and ongoing education
• work in a leading global clinical research organization

Responsabilità

• Plan, schedule, conduct, report and close audit activities across involved countries to assess compliance with regulations, guidelines, customer requirements, IQVIA SOPs and project guidelines
• Evaluate audit findings and prepare/distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, compliance status, and policies
• Consult with customers and monitors on interpreting audit observations and corrective action plans
• Review/approve investigations, RCA, CAPA and EC plans; track closure for quality events from audits or QA activities
• Evaluate policies/procedures for regulatory compliance and recommend process improvements
• Maintain the electronic quality management system (eQMS) and support audit lifecycle
• Lead/collaborate/support QA initiatives/projects for quality and process improvements
• Assist in training of new Quality Assurance staff
• May manage Quality Issues and present educational programs on compliance procedures
• May conduct pre-inspection visits, host audits/inspections, and assist in regulatory facility inspections as assigned

Requisiti fondamentali

• Certified to conduct audits in Italy per Italian Decree of the Ministry of Health (dated 15 Nov 2011)
• Travel 30-50% mainly in Europe
• 5 years experience in pharmaceutical/technical field, with 3 years in Quality Assurance Audits
• Experienced in conducting clinical trial Investigator site audits
• Experience in clinical study report/data management audits preferred
• Knowledge of word-processing, spreadsheet, and database applications
• Extensive knowledge of pharmaceutical R&D processes and regulatory environments
• Knowledge of quality assurance processes and procedures
• Strong interpersonal, problem solving, risk analysis, and negotiation skills
• Strong training, organization, communication, and team orientation skills
• Ability to work independently and manage multiple projects
• Ability to establish and maintain relationships with coworkers, managers and clients
• strong interpersonal skills
• excellent problem solving and negotiation
• effective training capabilities
• word-processing
• spreadsheets
• databases