Job Description
**GMP Quality Auditor** **Job Summary:** Conduct audits to ensure compliance with GMP regulations, assess systems and processes, and provide guidance on corrective actions. As a GMP Quality Auditor, you will be responsible for planning, coordinating, and performing pre, during, and post-audit activities for assigned audits. You will assess systems, processes, procedures, and records against applicable regulations, with a primary emphasis on GMP, IT, and quality audits that impact Regeneron operations and/or product. **Key Responsibilities:** * Maintain professional expertise and knowledge of audit criteria, including internal company policies and procedures, and applicable local and international regulations, standards, and guidelines. * Supervise industry trends with respect to regulatory agency findings, expectations, and warning letters. * Perform supplier/external audits and evaluate systems, processes, procedures, and records against applicable GxPs and audit criteria. * Collaborate with procurement, external manufacturing, quality, audit clients, and other stakeholders with respect to supplier/external audits. * Perform and maintain all required training and annual GMP training within required timelines. * Prepare written audit reports and documents in accordance with company and department procedures and requirements. * Provide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards. * Complete peer reviews of audit documentation and auditee responses. **Requirements:** * BS/BA with 5+ years of related experience in Biotech/Pharmaceutical industry. * Minimum of 3 years of prior auditing experience in a GMP environment. * Experience in aseptic filling operations and supplier auditing is preferred. * Ability to maintain integrity and honesty at all times. * Ability to work independently or as part of a team. * Ability to communicate with transparency.