Senior QA Auditor (GCP Audits) - Certified to Audit Sites in Italy
IQVIA · Milan · €47,500–€71,300 (stated in the posting)
Overview
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
This role offers the opportunity to independently lead audit activities across a diverse portfolio of clinical research programs and collaborate with global teams to support quality, compliance, and continuous improvement initiatives.
Core Responsibilities
- 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 and Preventive Action (CAPA) plans.
- Review, approve investigations, Root Cause Analysis (RCA), CAPA and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
- Perform pre-inspection visits at sites.
- 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 in, or support QA initiatives and process improvement projects.
Additional Responsibilities
- Depending on business needs, the role may also include:
- Assist in training of new Quality Assurance staff.
- Manage Quality Issues.
- Present educational programs and provide guidance to operational staff on compliance procedures.
- As assigned, host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
Required Qualifications
- Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 November 2011.
- Experience in the conduct of clinical trial Investigator Site Audits.
- Travel 30-50% mainly in Europe.
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
- Extensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Strong training capabilities and ability to initiate assigned tasks and work independently.
- Effective organization, communication and team orientation skills, with ability to manage multiple projects and establish and maintain effective working relationships with coworkers, managers and clients.
- Knowledge of word-processing, spreadsheet, and database applications.
Why Join IQVIA Quality Assurance
- Independently lead the full audit lifecycle, with a primary focus on Investigator Site Audits (ISAs) across a diverse portfolio of clinical research programs.
- Work within a global quality organization supporting international clinical research programs.
- Collaborate with experienced QA professionals and cross-functional teams across regions.
- Contribute to quality and compliance initiatives that support continuous improvement and operational excellence.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is € 47.500,00 - € 71.300,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.