Quality Compliance Specialist (Quality Risk Management)
Regeneron
August 14, 2026
On-site
East Greenbush, NY
Operations
Quality Compliance Specialist (Quality Risk Management)
Responsibilities:
- Support Internal Drug Product Manufacturing operations using quality risk management (QRM).
- Facilitate quality risk assessments, risk reviews, and other QRM programs supporting the Quality System (e.g., change control, deviation management).
- Provide technical expertise in QRM to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
- Facilitate data-driven risk assessments/reviews using methods such as 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 QRM program.
- Contribute to contamination control strategy (CCS) and aseptic processing risk assessments for fill/finish; interface with EM, utilities, and equipment owners.
- Prepare for and support regulatory, customer, and internal audits/inspections.
- Coach colleagues on QRM principles and drive consistent application.
- Track metrics (e.g., on-time risk reviews, cycle time) and identify continuous improvement opportunities.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field, or equivalent education/experience.
- Specialist: 2+ years relevant experience; Senior Specialist: 5+ years relevant experience (level based on experience).
- Excellent collaboration, influence, and communication; proficient in facilitating cross-functional discussions.
- Proficient digital literacy: Microsoft Word, Excel, PowerPoint; Veeva experience heavily preferred.
- Understanding of QRM principles.
- Ability to interpret complex technical/system information and make sound risk-based decisions.
Application:
- Apply now.
Responsibilities:
- Support Internal Drug Product Manufacturing operations using quality risk management (QRM).
- Facilitate quality risk assessments, risk reviews, and other QRM programs supporting the Quality System (e.g., change control, deviation management).
- Provide technical expertise in QRM to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
- Facilitate data-driven risk assessments/reviews using methods such as 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 QRM program.
- Contribute to contamination control strategy (CCS) and aseptic processing risk assessments for fill/finish; interface with EM, utilities, and equipment owners.
- Prepare for and support regulatory, customer, and internal audits/inspections.
- Coach colleagues on QRM principles and drive consistent application.
- Track metrics (e.g., on-time risk reviews, cycle time) and identify continuous improvement opportunities.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field, or equivalent education/experience.
- Specialist: 2+ years relevant experience; Senior Specialist: 5+ years relevant experience (level based on experience).
- Excellent collaboration, influence, and communication; proficient in facilitating cross-functional discussions.
- Proficient digital literacy: Microsoft Word, Excel, PowerPoint; Veeva experience heavily preferred.
- Understanding of QRM principles.
- Ability to interpret complex technical/system information and make sound risk-based decisions.
Application:
- Apply now.