Quality Compliance Specialist (Quality Risk Management)
Regeneron
5 months ago
On-site
East Greenbush, NY
Operations
Quality Compliance Specialist (Quality Risk Management)
Responsibilities:
- Provide technical expertise in quality risk management (QRM) to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
- Facilitate data-driven risk assessments and risk reviews using methodologies 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 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 continuous improvement opportunities.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field.
- At least 2 years of relevant experience (proven experience may substitute for education requirement).
Required/Preferred Skills:
- Understanding of QRM principles.
- Ability to interpret complex technical and systems information and make sound risk-based decisions.
- Organized with attention to detail; ability to prioritize multiple assignments and changing priorities.
- Excellent collaboration, influence, and communication skills; effective at facilitating cross-functional discussions.
- Proficient digital literacy in Microsoft Word, Excel, and PowerPoint required; experience with Veeva heavily preferred.
Application:
- Apply now to be considered for this role.
Responsibilities:
- Provide technical expertise in quality risk management (QRM) to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities.
- Facilitate data-driven risk assessments and risk reviews using methodologies 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 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 continuous improvement opportunities.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or related field.
- At least 2 years of relevant experience (proven experience may substitute for education requirement).
Required/Preferred Skills:
- Understanding of QRM principles.
- Ability to interpret complex technical and systems information and make sound risk-based decisions.
- Organized with attention to detail; ability to prioritize multiple assignments and changing priorities.
- Excellent collaboration, influence, and communication skills; effective at facilitating cross-functional discussions.
- Proficient digital literacy in Microsoft Word, Excel, and PowerPoint required; experience with Veeva heavily preferred.
Application:
- Apply now to be considered for this role.