Lead, Quality Systems
Genezen(1 month ago)
About this role
The Quality Systems Lead administers and enhances Genezen's Quality Management System with emphasis on electronic QMS support, risk assessments, inspection readiness, and regulatory compliance. The role ensures inspection and audit readiness, supports regulatory surveillance, and partners with cross-functional teams to maintain quality standards. This position drives continuous improvement initiatives and governance of quality-related documentation and processes.
Required Skills
- QMS
- EQMS
- Workflow Design
- Training
- Troubleshooting
- Reporting
- KPI Tracking
- Change Control
- CAPA
- Risk Assessment
+5 more
Qualifications
- Bachelor's Degree in Related Field
- Advanced Degree
- ASQ Certified Quality Auditor (CQA)
- ASQ Certified Manager of Quality (CMQ)
About Genezen
genezen.comGenezen is a contract development and manufacturing organization (CDMO) focused on viral vector production to accelerate gene and cell therapies. It provides expertise, GMP-capable facilities, and end-to-end capabilities to support process development, scale-up and commercial manufacturing for advanced biologics. Genezen positions itself as a partner to biotech and pharma teams, offering quality systems, analytical support, and manufacturing capacity to shorten timelines and reduce development risk.
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