Job Description
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 be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and quality audits that may impact Regeneron operations and/or product.A typical day might include, but is not limited to, the following:Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.)Supervising industry trends with respect to regulatory agency findings, expectations and warning lettersPerforming supplier/external audits and evaluating systems, processes, procedures and records against applicable GxPs and audit criteriaCollaborating with procurement, external manufacturing, quality, audit clients and other stakeholders with respect to supplier/external auditsPerforming and maintaining all required training and annual GMP training within required timelinesPerforming required lead auditor or support auditor activities as applicable for assigned auditsPreparing written audit reports and documents in accordance with company and department procedures and requirements; ensuring the quality and accuracy of all audit documentation; ensuring timelines for assigned audits are metProviding guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standardsCompleting peer reviews of audit documentation and auditee responses; ensuring requirements for audit documentation and auditee responses are metParticipating in IOPS inspection readiness, inspections/partner audits, and internal audits as neededNote this position requires approximately 50% travel, globallyThis role might be for you if:You have the ability to maintain integrity and honesty at all timesYou have the ability to work independently or as part of a teamYou have the ability to communicate with transparencyYou have previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory auditsYou have experience in understanding and interpreting regulatory guidelines and documentsTo be considered for this opportunity you must have a BS/BA with 5+ years of related experience in Biotech/Pharmaceutical industry. A minimum of 3 years of prior auditing experience in a GMP environment; experience in aseptic filling operations and supplier auditing is preferred. #J-18808-Ljbffr