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About the Role

Regeneron is seeking a Quality Compliance Specialist (Quality Risk Management) to support Internal Drug Product Manufacturing operations. This role applies patient-centered quality risk management across vital processes, including facilitating risk assessments and reviews within the Quality System.

Responsibilities

• Providing technical expertise in quality risk management to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
• Facilitating data-driven risk assessments and risk reviews using methodologies like FMEA, RBIA, REM, and HACCP.
• Partnering with Risk Assessment Owners to define scope, acceptance criteria, and evaluation scales.
• Guiding teams through risk identification, analysis, control/mitigation, and residual risk evaluation.
• Preparing and revising QRM documents.
• Developing and improving the quality risk management program.
• Contributing to contamination control strategy and aseptic processing risk assessments for fill/finish operations.
• Preparing for and supporting regulatory, customer, and internal audits/inspections.
• Coaching colleagues on QRM principles and driving consistency in application.
• Tracking metrics and identifying opportunities for continuous improvement.

Requirements

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

Skills

• Quality Risk Management (QRM)
• FMEA
• RBIA
• REM
• HACCP
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Veeva (preferred)

Location

• East Greenbush, New York, United States

Work Type

• On-site

Experience Level

• Specialist
• Senior Specialist

Education Level

• Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, Engineering or related field, or equivalent combination of education and experience

Salary/Compensations

• $67,400.00 - $128,700.00

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We believe we do our best work when we are together.

Equal Opportunity

• 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.