Senior QA Auditor - GCP Audits

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.

Essential Functions

• 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 during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, 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 Nov 2011.
• Travel 30-50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Experienced 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.

Compensation and Benefits

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.