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
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