GMP Quality Auditor

4 weeks ago

Ireland Regeneron Pharmaceuticals, Inc Full time

Within this role 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.

Note this position requires approximately 50% travel globally.

As a GMP Quality Auditor, a typical day might include, but is not limited to, the following:

  • Maintaining professional expertise and knowledge of audit criteria including 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 letters

  • Performing supplier/external audits and evaluate systems, processes, procedures and records against applicable GxPs and audit criteria

  • Collaborating with Procurement, External Manufacturing, Quality, audit clients and other stakeholders with respect to supplier/external audits

  • Performing and maintain all required training and annual GMP training within required timelines

  • Performing required lead auditor or support auditor activities as applicable for assigned audits

  • Preparing written audit reports and documents in accordance with company and department procedures and requirements; ensuring the quality and accuracy of all audit documentation; ensure timelines for assigned audits are met

  • Providing mentorship and support in the development of corrective and preventive actions based on GxP requirements and industry standards

  • Completing peer reviews of audit documentation and auditee responses; ensure requirements for audit documentation and auditee responses are met

  • Participating in IOPS inspection readiness, inspections/partner audits, and internal audits as needed

  • Performing other duties and responsibilities as assigned by management

This role might be for you if:

  • You have the ability to maintain integrity and honesty at all times

  • You have the ability to work independently or as part of a team

  • You have the ability to communicate with transparency

  • You have previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits

  • You have experience in understanding and interpreting regulatory guidelines and documents

To be considered for this opportunity you must have a BS/BA with 4+ years of related experience in Biotech/Pharmaceutical industry. A minimum of 2 years of prior auditing experience in a GMP environment; experience in aseptic filling operations and supplier auditing is preferred.

#LI-Onsite #JOBSIEPR #IRELIM #REGNIEQA

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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