Senior Director, GMP Quality

Senior Director of GMP Quality will establish and maintain quality systems, provide oversight of manufacturing partners and testing laboratories, and ensure regulatory compliance. This hands-on leadership role partners with cross-functional teams from development through commercialization and reports to the Vice President of Quality.

Responsibilities

• Establish scalable, risk-based quality framework for analytical, manufacturing, and validation activities
• Provide independent quality oversight of CMC strategies, control strategies, and specifications
• Lead quality relationships with external partners including audits and performance management
• Advise Technical Operations, Regulatory Affairs, and executive teams on quality and regulatory readiness
• Foster quality culture focused on scientific rigor and proactive risk management

Requirements

• Extensive GMP quality systems and CMC strategy experience
• Knowledge of analytical testing, manufacturing, validation, and lifecycle management
• Experience managing relationships with CDMOs and contract laboratories
• Understanding of regulatory requirements and GxP compliance
• Leadership experience building quality culture and risk management practices
• Ability to advise senior leadership on product quality and supply continuity