Quality Systems Improvement Specialist
Guerbet · Raleigh, NC · 2 wk ago
On-siteQuality AssuranceFull-time
Qualifications
- Bachelor’s degree in Life Sciences, Quality, Engineering, or a related field (or equivalent combination of education and experience).
- 10+ years of experience in pharmaceutical Quality Assurance, Quality Systems, or Quality Compliance within a GMP-regulated environment.
- Demonstrated experience contributing to Quality Management System (QMS) improvements or transformation initiatives.
- Strong expertise in root cause analysis, CAPA systems, and quality governance frameworks.
- Solid understanding of 21 CFR Parts 210 and 211 and general GMP regulatory expectations.
- Practical experience applying Quality Risk Management (ICH Q9) principles and risk-based decision-making.
Requirements
- Experience working in sterile manufacturing or terminal sterilization environments.
- Knowledge of global regulatory expectations for sterile products (e.g., FDA, EMA, PIC/S).
- Experience supporting regulatory inspections, audit readiness, or quality system remediation efforts.
Benefits
This role is a contract role that will last 18-24 months and will be eligible for Guerbet benefits.