Senior Supplier Quality Assurance Specialist GMP Materials

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

This on-site role in Rensselaer, NY offers a Monday–Friday schedule with a total rewards package. You will coordinate supplier change notifications globally, support deviations and CAPAs, and maintain controlled documents.

Qualifications

• Bachelor's degree in scientific subject area or related field; relevant years of experience per level: Specialist: 2+ years; Sr. Specialist: 5+ years.

Responsibilities

• 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
• Maintain and update-controlled documents related to supplier change notification.
• Supports execution of 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.
• Experience partnering with suppliers of GMP materials/components preferred.
• Previous quality experience in a GMP environment.

Skills

Supplier Change Notifications

GMP

Quality Assurance

Education

Bachelor's degree in scientific subject area

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

This on-site role in Rensselaer, NY offers a Monday–Friday schedule with a total rewards package. You will coordinate supplier change notifications globally, support deviations and CAPAs, and maintain controlled documents.