JCW is partnering with a late-stage biotech organization looking for a senior quality leader to drive GMP Quality Operations across manufacturing as they advance toward commercialization.

Key Focus:

• Lead GMP QA strategy and Quality-on-the-Floor oversight
• Support clinical to commercial readiness
• Oversee QC, batch release, and materials/distribution quality
• Drive inspections, audits, deviations, and CAPAs

Background:

• 10+ years in GMP Quality (biologics, sterile, or cell & gene therapy)
• Strong knowledge of FDA/EMA regulations
• Proven leadership in building teams and scaling quality systems

High-visibility role with strong impact on product delivery to patients