Senior Quality Assurance Specialist
Regeneron Pharmaceuticals
Summary
At Regeneron, we apply science and innovation to create life-changing medicines for people living with serious diseases. We are looking for a Sr. Quality Assurance Specialist to support our Drug Product Manufacturing (Internally). In this role, you will be a partner by providing leadership-level quality oversight and responsible for accomplishing quality objectives by planning and evaluating project activities.
Job description
Essential Duties and Responsibilities
- Provides operational support including formulation, fill/finish, assembly, packaging and labeling activities.
- Acts as an interface with Manufacturing Project Managers or Internal Project Managers for all quality related issues at the suppliers or internally at the fill/finish site.
- Resolves problems, identifies trends and determines system improvements across multiple programs and sites.
- Ensures compliance with internal procedures and regulatory expectations by proactively working across site.
- Support audit and inspection readiness across Quality Assurance which may include assisting as needed in audits and inspections while tracking readiness.
- Communicating and tracking compliance and regulatory requirements cross-departmental.
- Prepares and completes action plans; implementing productivity, quality and customer-service standards.
- Implements change, when necessary, within the guidelines of GMP manufacturing operations.
- May support primary component and secondary components and packaging operations and suppliers.
- Oversees multiple projects as needed
Requirements
- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
- Sr Specialist: 6+ years of proven experience
Benefits
- Annual bonuses
- Incentive plans
- 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.