Senior Director, GMP Quality

📋 Description

• Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing
• Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies
• Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory
• Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk
• Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other
• Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage

🎯 Requirements

• Bachelors degree in a relevant scientific discipline and 15+ years of biopharmaceutical industry
• Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP
• Strong understanding of quality systems, including deviations, investigations, CAPAs, change
• Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality
• Strong knowledge of biologic products regulations, process validation, method validation
• Proven ability to establish phase-appropriate Quality strategies and scalable systems for early-

🎁 Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package