Clinical QA Auditor IV

Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and to enhance the quality of life. We also seek to provide a return to shareholders that reflects our performance and to adequately reward those who invest ideas and resources in our company.

Novartis Vaccines is growing! In this newly created position you will be responsible for conducting study audits at investigator sites in North America and Latin America. Responsibilities include: Conduct document audits such as Informed Consents, Clinical Study Reports, Safety Reports and other audits and assessments as required. Conduct internal system and vendor audits. Prepare written audit reports using the audit report database. Evaluate the adequacy and completeness of corrective and preventive action plans (CAPA) and follow up on CAPA to closure. Track progress of projects/studies to be audited for planning and scheduling purposes. Maintain required knowledge of applicable regulations and government, industry and company GCP standards and procedures. Serve as a CQA representative on study team meetings to assure effective audit planning and adequate coverage of clinical research activities. May serve as a compliance consultant on SOP working teams for cross functional units. Assist in initiating series of educational discussions within Clinical Research & Medical Affairs staff on select GCP topics and/ or questions. Take a lead role in the review of CQA SOPs and support the development of CQA procedures and guide-lines. Assist and support regulatory inspections in the regions specified. Requirements: Bachelor's degree with 3 +years of GCP Auditing and/or experience working in a clinical research setting. Experience setting up and overseeing clinical trials, doing site audits/inspections, and managing required clinical documentation a plus. Industry, academic or CRO experience required. Position requires 25 - 50% travel in North America and Latin America. and or clinical research experience.Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world's fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an equal opportunity employer.