Manager Quality Risk Management
Regeneron Pharmaceuticals
Summary
Regeneron is hiring a Manager Quality Risk Management (QRM) to join the team at a new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the implementation of the QRM Governance process globally at Regeneron Industrial Operations & Product Supply (IOPS) sites, ensuring compliance with global regulations and standards set forth by governing regulatory and accrediting agencies. They will also support other departments and project teams in meeting quality and business objectives as they relate to GxP risk management.
Job description
When & where
- Location: Initial: Rensselaer, New York, United States; Permanent: Saratoga Springs, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
Discover your role
- Works with all departments across IOPS to identify risk-based tools and methodologies to support efficiency and compliance related improvements at both a local and global level
- Formulate risk management principles, methods and tools, and documents in appropriate Regeneron policies, procedures, and reports
- Ensure that staff are educated and trained (cross sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters
- Lead data driven risk assessments (risk identification, analysis, and ranking)
- Provide ongoing collaboration, engagement, and education to cross-functional teams members in the application and compliance of risk assessment and mitigation processes
- Implement QRM program to ensure risk assessments are conducted at required frequencies and manage the overall process, tasks, and communications
- Communicate the outcome from quality risk management activities and periodic site-wide reviews
- Works with the QRM Management team to integrate quality risk management concepts and philosophies into the overall Quality System
- Develop, coach, and support direct reports and broader team to build a sustainable QRM organization
- Manages a team to ensure proper maintenance of risk documents and support of new risk assessments for IOPS
- Represent Regeneron’s approach to QRM during regulatory inspections and partner audits
- Represent QRM team as subject matter expert in risk management governance processes
This role requires
- BS/BA in Biological Sciences, Chemistry or Biochemistry or a related field; or equivalent combination of education and experience
- Associate Manager Quality Risk Management: 6+ years of experience
- Manager Quality Risk Management: 7+ years of experience
- Level will be determined based on experience
- Previous people leadership/ supervisory experience
- Experience with recombinant protein manufacturing or development of manufacturing processes
Requirements
- BS/BA in Biological Sciences, Chemistry or Biochemistry or a related field; or equivalent combination of education and experience
- 7+ years of experience for Manager level
- Previous people leadership/ supervisory experience
- Experience with recombinant protein manufacturing or development of manufacturing processes
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension Or Retirement Benefits
- 401(k) Company Match
- Health And Wellness Programs
- Fitness Centers
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- 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.