Manager Quality Risk Management

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.  We’re 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 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 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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 accom