Principal QA Material Supplier Specialist (Change Notification)
Regeneron
RENSS - TEMPEL LN, Unknown
Full-Time
$78,700
OfficeSenior
Build our future together:
Our Material & Supplier Quality Assurance team is hiring a Principal QA Material Supplier Specialist to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply. This role provides global coordination for supplier change notifications.
When & where:
Rensselaer, NY
Monday-Friday
Discover your role:
Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross functional impact evaluation, communication, and closure.
Supports the resolution of internal and external deviations, and Supplier Corrective Action Requests (SCARs) related to materials and supplier changes.
Maintain and update controlled documents related to supplier change notification.
May execute Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
Performs continuous improvement of the Material & Supplier Quality program with a focus on SCN workflow efficiency, cycle time reduction, and right first time.
Manages and tracks projects to ensure milestones are achieved while complying with established timelines.
This role requires:
A Bachelor’s degree in scientific subject area or related field and the following years of experience for each level:
Sr. Specialist: 5+ years
Principal Specialist: 8+ years
Experience partnering with suppliers of GMP materials/components preferred.
Previous quality experience in a GMP environment.
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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.
Salary Range (annually)