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 e

QMS, 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 (e

QMS) 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