The Regeneron Associate Manager, Audit Operations is a key position in the Global Development Quality Assurance (GDQA) group with primary responsibility for management of Corrective and Preventative Actions from external audits and to assist with procedural and system management and oversight of resourcing as requested. The Associate Manager, Audit Operations should have industry experience as well as have a solid knowledge of Good Clinical (GCP), Good Laboratory (GLP), and/or Good Pharmacovigilance (GVP) Practice (GxP), Computer System Validation (CSV) and FDA and EU regulations and guidance documents, as applicable, within the role. Depending on experience, the Associate Manager, Audit Operations may assist with audit conduct as well as audit strategy. The overall goal for the Associate Manager Audit Operations is to independently support all aspects of the Operations role.

• Excellent communication skills and ability to work with people at all levels of the organization and externally
• Excellent technical skills, prior experience with Sharepoint and TEAMS a plus
• Demonstrated skills in taking initiative and working independently
• Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
• Strong leadership with demonstrated ability to interface with senior leaders

In order to be considered qualified for this role , you must have:

• Bachelor’s degree with 5+ years of relevant industry or clinical research experience
• 3+ year’ experience working in either a GxP compliance group, QA Quality Management /Quality Risk Management function, or Clinical Development

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.