Senior QA Auditor (GCP Audits) - Certified to Audit Sites in Italy

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.

• →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.

• →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.

• 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.