5h ago
Manager/Senior Manager, Quality Assurance, Bioanalytical
Lincoln, NE
✨ $120k-$160k / yearest.
full-timeleadClinical Research
💼 About This Role
You'll lead the QA Bioanalytical team and drive QMS and process improvement initiatives for a dynamic clinical research organization. Your work will ensure quality and compliance across studies, audits, and regulatory inspections, directly accelerating drug development.
🎯 What You'll Do
- Direct and manage the QA Bioanalytical team
- Oversee study, system/process, and vendor audits
- Host sponsor audits and regulatory inspections
- Contribute to global QA strategy
📋 Requirements
- Bachelor's degree in Business, Science, or related field
- 8-10 years experience in Quality Assurance
- 4-5 years team management experience
- GXP regulations (GLP and/or GCP) and FDA 21 CFR Part 11
✨ Nice to Have
- PhD or advanced degree
- Experience in bioanalytical or pharmaceutical industry
- Proficient knowledge of bioanalytical techniques
🎁 Benefits & Perks
- 🏖️ Hybrid working options
- 💼 Opportunity to impact drug development
- 🌍 Global team collaboration
- 📈 Career growth in a dynamic environment
0 0 0