Manager Quality Risk Management

Regeneron Pharmaceuticals, Inc (USA); United States; Sur place; USD 92 000 - 176 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) in Saratoga Springs is seeking a Manager Quality Risk Management to lead the global QRM Governance across IOPS sites and ensure compliance with global regulations.

You will develop risk management principles, educate cross-site staff, perform data-driven risk assessments, and integrate QRM concepts into the Quality System while guiding a team and supporting regulatory inspections.

Qualifications

• Lead global QRM Governance across Regeneron IOPS sites and ensure compliance with global regulations and standards.
• Formulate risk management principles, methods and tools, and document in Regeneron policies and reports.
• Educate staff cross-site in quality risk management and act as a subject matter expert.
• Lead data-driven risk assessments (identification, analysis, ranking) and mitigate risks.

Responsabilités

• Collaborate with cross-functional teams to apply QRM across processes.
• Communicate outcomes from QRM activities and site-wide reviews.
• Develop, coach and support the QRM team to sustain governance.
• Represent Regeneron’s QRM approach during regulatory inspections and audits.

Connaissances

People leadership

Quality risk management

Cross-functional collaboration

Manufacturing process experience

GxP knowledge

Formation

BS/BA in Biological Sciences, Chemistry or Biochemistry or related field

Description du poste

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.

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

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.

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.

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

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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.