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; ensure the quality and accuracy of all audit documentation; ensure 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; ensure requirements for audit documentation and auditee responses are metParticipating in IOPS inspection readiness, inspections/partner audits, and internal audits as neededPerforming other duties and responsibilities as assigned by managementNote this position requires approximately 50% travel, globally.To 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.Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. #J-18808-Ljbffr