Summary: Responsible for assisting management with ensuring auditors have the education, experience and/or training necessary to be able to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program.
Responsible for planning, coordinating and performing pre-, during and post-audit activities for assigned audits.
Extensive knowledge of USA and EU GxP regulations is required.
Essential Duties and Responsibilities include, but are not limited to, the following: Maintain 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.
); Monitor industry trends with respect to regulatory agency findings, expectations and warning letters; Lead and/or participate in the development and maintenance of department processes and procedures to ensure compliance with current regulatory requirements; Assist management with the maintenance and continuous improvement of the auditor training program, oversight of the training and qualification of auditors, and the development and maintenance of continuing auditor education; Ensure written and departmental procedures, timelines and requirements are followed and met; Assist with audit scheduling and audit assignments as needed.
Assist with the oversight, selection, training, onboarding and assessment of proxy auditors; Perform review of audit documentation (audit reports, audit responses, extensions, etc.)
for purposes of training, peer review, approval and/or audit closure; 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; Perform required lead auditor or support auditor activities as applicable for assigned audits; Prepare 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 met; Provide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards; Participate in IOPS inspection readiness, inspections/partner audits, and internal audits as needed; Perform other duties and responsibilities as assigned by management.
**This position requires approximately 50% travel, globally** Education and Experience: BS/BA with 8+ years of related experience in Biotech/Pharmaceutical industry; other relevant experience may be considered in lieu of degree or equivalent combination of education and experience.
A minimum of 8+ years of Quality Management experience in a GMP environment with prior supplier auditing experience; experience in aseptic filling operations is preferred.
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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.
