Quality Assurance Director

Job Summary

A company is looking for a Director, Quality Assurance, Drug Substance.

Key Responsibilities

• Oversee quality and compliance of cell bank and biologics drug substance manufacturing
• Implement strategies to promote and maintain GxP compliance
• Collaborate with contract manufacturers and internal stakeholders to address deviations and compliance issues

Required Qualifications

• Bachelor's degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field; advanced degree preferred
• Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting
• Minimum 6+ years in a GMP QA role, with direct experience in Manufacturing or QC preferred
• In-depth knowledge of FDA, ISO, EMA, GMP, and ICH quality systems and regulatory requirements
• Experience working with external partners and biologics drug substance manufacturing