Senior Manager, Quality Risk Management

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 92,000 - 176,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Risk Mgmt

GxP Compliance

Regulatory Inspections

Cross-functional Leadership

Data-driven Risk Assessment

Staff Training

Team Leadership

Education

BS/BA in Biological Sciences, Chemistry or Biochemistry

Job description

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.