In this role you will be responsible for overseeing and maintaining all cGMP compliance aspects of procurement operations.

A typical day might include the following:

• Supervising progress on all Strategic Sourcing & Procurement quality system results, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates

• Interfacing with Quality Assurance and other functional areas, removing obstacles, resolving conflicts, and facilitating critical decisions pertaining to quality system results

• ·Performing deviation investigations and coordinates CAPA implementation as needed for high risk events

• Continually reassess’ Strategic Sourcing & Procurement systems and processes for adherence to cGMPs and industry standards and implements changes/improvements as needed

• Monitoring, reporting, and responding to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations

• Representing the department on various topics during regulatory inspections, and coordinates responses to inspection observations as applicable

• Managing the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers

• Driving successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures and gathering of evidence of closure for raw material and component suppliers

This role may be for you if you:

• Demonstrate excellent technical and analytical skills

• Have a proven track record in Quality / Compliance

• You possess strong communication and teamwork skills

• You are adaptable and can work in a fast-paced, regulated environment

In order to be considered for this position, you must hold a Bachelor’s degree in a related field with 6+ years of relevant experience, with at least 5+ years of experience in a cGMP environment. 

#LI-Onsite #JOBSIEPR #IRELIM

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.