Global Quality Risk Manager - Lead QRM Governance

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 92,000 - 176,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

People leadership

Quality risk management

Cross-functional collaboration

Manufacturing process experience

GxP knowledge

Education

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

Job description

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.