Offer summary

Qualifications:

Bachelor’s degree with 5+ years of industry or clinical research experience., At least 3 years of experience in GxP compliance, QA Quality Management, or Clinical Development., Knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP)., Understanding of FDA and EU regulations, Computer System Validation (CSV), and audit processes..

Key responsibilities:

Assist with managing external audit CAPA processes and quality event systems.

Support GDQA procedures, including SOP and deviation management.

Represent GDQA on cross-functional teams and compliance projects.

Support audit conduct and strategy, including scheduling and reporting audits.

Job description

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.

A typical day might look like:

Assist with the oversight of GDQA systems management including Managing external Audit CAPA process, Quality Event Management System (QEMS) Audit Support, Supporting GDQA Trend Analysis & Metrics Review [identify and escalate positive and negative trends]
Assist with the oversight of GDQA Procedures, which may include the following identifying & managing SOP/WI/BPT/Template improvement, , monitoring and managing Procedural Deviations
Represent GDQA on teams, compliance projects and initiatives both within and across functional areas of Global Development, or other departments, as applicable
While not a primary role, the Audit Operations group may also schedule, prepare, conduct, report and follow-up on audits in support of GCP Audit group as needed. This role may require 10 – 20% travel (both domestic and international)
May support clinical studies as a strategy representative to develop and execute risk-based audit programs for assigned studies (GCP).

This role may be for you if you have:

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.

Salary Range (annually)

$96,700.00 - $157,700.00

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