Description
We are seeking a Clinical Audit Manager to plan and conduct independent clinical audits to assess compliance with regulations, guidelines, and operating procedures. You will prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Additionally, you will provide consultation in interpretation of regulations, guidelines, policies, and procedures.
Core Responsibilities
- Plan, schedule, conduct, report and close audit activities in various countries 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.
- Review, approve investigations, Root Cause Analysis (RCA), CAPA and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits.
- 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
- Assist in training of new Quality Assurance staff.
- Manage Quality Issues.
- Present educational programs and provide guidance to operational staff on compliance procedures.
- 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.