Quality Compliance Specialist (Quality Risk Management)
Regeneron · Tempel LN
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Regeneron seeks a Quality Compliance Specialist to support internal drug product manufacturing through quality risk management (QRM) application across manufacturing operations. The role involves facilitating risk assessments, developing QRM programs, and coaching cross-functional teams on risk management principles. A bachelor's degree in a relevant scientific or engineering field plus 2+ years of experience is required.
What they're looking for
- Bachelor's degree in biological sciences, chemistry, biochemistry, engineering, or related field
- 2+ years relevant quality risk management work experience for specialist level
- 5+ years relevant experience for senior specialist level
- Strong cross-functional collaboration and communication abilities
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Understanding of quality risk management principles and methodologies
- Ability to interpret complex technical information and make risk-based decisions
What you'll be doing
- Provide quality risk management expertise to manufacturing, quality assurance, and other operational teams
- Facilitate data-driven risk assessments using methodologies like FMEA, RBIA, and HACCP
- Guide teams through risk identification, analysis, mitigation, and residual risk evaluation
- Prepare and revise quality risk management documentation and support audits/inspections
- Track program metrics and identify continuous improvement opportunities
Privacy & handoff
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