Senior QA Auditor - GCP Audits

Responsibilities

• Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures.
• 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 similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
• Lead/collaborate/support QA initiatives/projects for quality and 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.

Qualifications

• The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 November 2011.
• Travel 30–50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Experience in the conduct of clinical trial investigator site audits.
• Experience in the conduct of clinical study report / data management clinical trial audits is preferred.
• 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.

The potential base pay range for this role, when annualized, is €47,500.00 – €71,300.00. Depending on qualifications, incentive plans, bonuses or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is committed to integrity in its hiring process and maintains a zero tolerance policy for candidate fraud. False statements may result in disqualification or termination of employment.