Senior Quality Assurance Specialist, Material Supplier
About The Position
Regeneron’s Material & Supplier Quality Assurance team is hiring a Senior Quality Assurance Specialist to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply. The role provides global coordination for supplier change notifications and is based in Rensselaer, New York. The stated work schedule is Monday through Friday, 8:00 AM to 4:30 PM. The position reviews and coordinates Supplier Change Notifications across global suppliers, from intake and triage through risk assessment, cross-functional impact evaluation, communication, and closure. It also supports deviation resolution, controlled-document maintenance, CAPAs, audits and regulatory inquiries, and continuous improvement of the Material & Supplier Quality program. Project tracking and adherence to established timelines are also part of the role.
Requirements
- Bachelor’s degree in a scientific subject area or related field, or proven experience may be substituted for the education requirement.
- At least 5 years of experience for the Senior Specialist level.
- Previous quality experience in a GMP environment.
Nice To Haves
- Experience partnering with suppliers of GMP materials or components.
Responsibilities
- Review and coordinate Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross-functional impact evaluation, communication, and closure.
- Support the resolution of internal and external deviations.
- Maintain and update controlled documents related to supplier change notification.
- Support execution of Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
- Gather, evaluate, and provide information and documentation to support regulatory inspections and inquiries, partner audits, and internal audits.
- Continuously improve the Material & Supplier Quality program, focusing on SCN workflow efficiency, cycle time reduction, and right first time.
- Manage and track projects to ensure milestones are achieved while complying with established timelines.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
