Senior Quality Assurance Specialist, Material Supplier
Regeneron Pharmaceuticals
Summary
Our Material & Supplier Quality Assurance team is hiring 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, compliance, and supply. This role provides global coordination for supplier change notifications.
Job description
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
- Maintain and update-controlled documents related to supplier change notification.
- Supports 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:
- Bachelor’s degree in scientific subject area or related field and the following years of experience for each level:
- Specialist: 2+ years
- Sr. Specialist: 5+ years
- May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Requirements
- Bachelor’s degree in scientific subject area or related field
- 5+ years of relevant experience for Sr. Specialist level
- Previous quality experience in a GMP environment
- Experience partnering with suppliers of GMP materials/components preferred
Benefits
- Annual bonuses
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.