Job Title
Auditing and Compliance Professional
* Plan, coordinate and perform pre-, during and post-audit activities for assigned audits.
* Maintain professional expertise and knowledge of audit criteria including internal company policies and procedures, and applicable local and international regulations, standards and guidelines.
* 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.
Required Skills and Qualifications:
* BS/BA degree with 8+ years related experience in Biotech/Pharmaceutical industry or equivalent combination of education and experience.
* A minimum of 8+ years Quality Management experience in a GMP environment with prior supplier auditing experience.
* Extensive knowledge of USA and EU GxP regulations.
Benefits:
We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees at all levels.
Others:
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.