Manager Quality Risk Management

Regeneron Pharmaceuticals; Saratoga Springs (UT); Vor Ort; USD 92.000 - 176.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is seeking a Manager Quality Risk Management to lead the implementation of QRM governance across IOPS sites. The role ensures compliance with global regulations, develops risk assessment methods, and educates teams on QRM principles worldwide.

The position requires 7+ years in QRM leadership, experience in protein manufacturing, and strong collaboration across departments to drive risk-based improvements.

Qualifikationen

• 6+ years in Associate Manager level or 7+ years Manager level Quality Risk Management experience.
• Experience with recombinant protein manufacturing or development of manufacturing processes.
• Previous people leadership/supervisory experience.

Aufgaben

• Identify risk-based tools and methodologies to support improvements at local and global levels.
• Formulate risk management principles, methods, and documents in Regeneron policies and reports.
• Educate staff across sites in quality risk management and act as SME.
• Lead data driven risk assessments (identification, analysis, ranking).
• Collaborate with cross-functional teams on risk assessment and mitigation.
• Implement QRM program and manage tasks and communications.
• Represent QRM during regulatory inspections and audits.

Kenntnisse

Quality Risk Mgmt

GxP Compliance

Regulatory Inspections

Cross-functional Leadership

Data-driven Risk Assessment

Staff Training

Team Leadership

Ausbildung

BS/BA in Biological Sciences, Chemistry or Biochemistry

Jobbeschreibung

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? 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 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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