Quality Compliance Specialist (Quality Risk Management)

Role: Support Regeneron's internal drug product manufacturing through quality risk management (QRM), ensuring compliance and process integrity. Responsibilities: facilitate risk assessments (e.g., FMEA, RBIA), develop and refine QRM programs, assist with contamination control and aseptic processing risk evaluations, prepare documentation, and aid regulatory audits. Collaborate across Quality, Manufacturing, Facilities, and Medical Devices; coach colleagues on QRM principles; track metrics for continuous improvement. Requirements: Bachelor's in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field; 2+ years (Specialist) or 5+ years (Senior Specialist) relevant experience; proficiency in MS Word, Excel, PowerPoint, preferably Veeva; strong communication and cross-functional facilitation skills; applicable knowledge of QRM principles. High-Value: GxP environment, manufacturing operations supporting biologics or drug production, contamination control, aseptic processing, regulatory audits, process risk assessments. WorkSetup: on-site East Greenbush, NY; Monday-Friday, 8 am-4:30 pm; travel not specified.