The Staff IT Compliance Analyst is responsible for ensuring that the manufacturing IT group operates in compliance with regulatory requirements and Regeneron internal procedures, and for managing internal and external audits.
As a Staff IT Compliance Analyst, a typical day might include the following:
* Provide expert analysis and guidance to the manufacturing IT team in regulatory/quality areas and manage an internal program to prepare for internal and external audit readiness.
* Evaluate, develop and modify manufacturing IT policies and standard operating procedures, plus company practices, to meet regulatory and corporate requirements and obligations.
* Represent and assist manufacturing IT SMEs during internal and external audits and lead the responses to audit findings.
* Establish, maintain and improve metrics to track IT compliance & inspection readiness and communicate those findings.
* Work collaboratively with our global sites to ensure deployed systems are managed and supported to meet compliance expectations and requirements of the business while championing data integrity.
* Monitor industry‑wide trends in audit observations, assess gaps if any, and take timely appropriate actions.
* Perform other duties assigned by IT management, demonstrating flexibility and a broad understanding of IT functions (e.g., IT deviations, IT change controls, creating/updating IT documents).
This Role May Be For You If You Have
* A deep understanding of GXP regulations (FDA 21 CFR Part 11, EU Annex 11) and IT systems validation/qualification.
* 3+ years of experience with IT systems used in regulated environments.
* 5+ years of experience in IT compliance within the biotechnology or pharmaceutical industry.
Experience & Education Requirements
* Principal IT Compliance Analyst: 10 years of relevant experience.
* Staff IT Compliance Analyst: 12 years of relevant experience.
* Equivalent combinations of education and experience may be considered; level is determined based on qualifications relevant to the role.
* Quality Assurance (QA) experience strongly desired.
* Experience in the pharmaceutical or biotechnology industry preferred.
Does this sound like you? Apply now to take your first step toward 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.
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 to verify certain information about a candidate prior to the commencement of employment, such as identity, right to work, educational qualifications, etc.
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