Quality Compliance Specialist (Quality Risk Management)

About the Role

This position supports Regeneron’s Internal Drug Product Manufacturing operations through the use of quality risk management (QRM). The role involves the broad application of patient-centered QRM across a full spectrum of processes vital to operations, including the active facilitation of quality risk assessments, risk reviews, and other quality risk-based programs supporting the Quality System (e.g., change control, deviation management, etc.).

Responsibilities

• Provide technical expertise in quality risk management to a broad base of customers throughout the organization, including Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
• Facilitate data-driven risk assessments and risk reviews using appropriate methodologies (e.g., FMEA, RBIA, REM, and HACCP).
• Partner with Risk Assessment Owners to define scope, acceptance criteria, and evaluation scales.
• Guide teams through risk identification, analysis, control/mitigation, and residual risk evaluation.
• Prepare and revise QRM documents.
• Develop and improve the quality risk management program.
• Contribute to contamination control strategy (CCS) and aseptic processing risk assessments for fill/finish operations; interface with EM, utilities, and equipment owners.
• Prepare for and support regulatory, customer, and internal audits/inspections.
• Coach colleagues on QRM principles and drive consistency in application.
• Track metrics (e.g., on-time risk reviews, cycle time) and identify opportunities for continuous improvement.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field, or equivalent combination of education and experience.
• Relevant work experience:
  • Specialist: 2+ years
  • Senior Specialist: 5+ years
• Level will be determined based on experience.
• Excellent collaboration, influence, and communication skills.
• Proficiency at facilitating cross-functional discussions.
• Proficient digital literacy in Microsoft (MS) Word, Excel, and PowerPoint; experience with Veeva is heavily preferred.
• Understanding of QRM principles.
• Ability to interpret complex technical and systems information and make sound risk-based decisions.

Location & Schedule

East Greenbush, New York, United States

Work schedule: Monday-Friday, 8:00 AM - 4:30 PM

Pay

Salary Range (annually): $67,400.00 - $128,700.00

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.
• Family support benefits.

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, additional information will be provided during the recruitment process.