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 the interpretation of regulations, guidelines, policies, and procedures. Support management in the promotion and assessment of compliance with 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, policies and procedures.
- Provide consultation to customers and monitors in the 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, 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, and support QA initiatives/projects for quality and process improvements.
- Assist in training new Quality Assurance staff.
- Manage Quality Issues as required.
- Present educational programs and provide guidance to operational staff on compliance procedures.
- 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.
- 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.
EEO Minorities/Females/Protected Veterans/Disabled
