OverviewAs 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 / Benefitshealth 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
ResponsabilitàPlan, 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 fondamentaliCertified to conduct audits in Italy per Italian Decree of the Ministry of Health (dated 15 Nov ****)
Travel *****% 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

📌 Senior Qa Auditor - Gcp Audits (Varese)
🏢 Iqvia
📍 Varese