15 set - Varese
Iqvia
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 pro
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