About this opportunity
BioSpace lists this Manager Quality Risk Management opportunity in city of saratoga springs, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Were hiring a Manager Quality Risk Management (QRM) to join our team at our 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.
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 Regenerons 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 experienceAssociate 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
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process.
Please be advised that at Regeneron, we believe we do our best work when we are together.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually) $92,200.00 - $176,000.00
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.