3h ago

Senior Director, IDMO Site Quality

Bridgewater, NJ

$90k-$210k / year

full-timedirectorbiotechnology

💼 About This Role

You'll lead the Quality organization for a cell therapy manufacturing facility, ensuring cGMP compliance from launch through commercial production. Your core impact will be developing and executing quality strategies that enable timely product release to patients. This role stands out for its multidisciplinary leadership across operations, regulatory, and cross-functional teams.

🎯 What You'll Do

  • Lead and develop QA/QC team for cell therapy production
  • Interface with cross-functional teams for manufacturing and release
  • Establish KPIs and monitor quality progress
  • Participate in regulatory and internal audits

📋 Requirements

  • 10+ years of Quality Management in cGMP biotech
  • 5+ years of senior leadership experience
  • Cell/Gene Therapy and CDMO experience
  • Knowledge of Quality Systems (GMP, FDA, GAMP, ISO)

🎁 Benefits & Perks

  • 💰 Competitive salary with range $90k-$210k
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