Therapist

• Lead and develop a global quality organization to support next-generation manufacturing automation, testing platforms, and digital initiatives for autologous CAR T and cell therapy products.
• Set the quality strategy and compliance standards for the AMS, AQC, QMS, and associated supply chain processes.
• Ensure that all systems and processes meet regulatory requirements and internal standards, including successful GMP qualification, validation, and routine operation.
• Partner closely with Automation, Engineering, Process Development, Regulatory, Supply Chain, and CMC teams to enable timely execution of manufacturing initiatives and launches.
• Oversee the development, execution, and continuous improvement of quality systems to support novel manufacturing technologies and digitized workflows.
• Serve as the primary quality decision maker for technical risk mitigation on automation of deviation management, CAPA, and other Quality Systems workstreams for implementation of QMS initiatives.
• Provide robust quality oversight for change management, comparability, and process control strategies for new cell process manufacturing and vector platforms.
• Review and approve quality sections of regulatory submissions, dossiers, and communications to health authorities, including responses to regulatory/inspection questions.
• Ensure automation adheres to quality and compliance standards for warehouse, logistics, planning, and scheduling operations in support of cell therapy product distribution.
• Foster a culture of innovation, agility, collaboration, and inclusion within the quality team, while maintaining a strong compliance and quality mindset.
• Establish and meet ambitious quality performance and compliance metrics in alignment with business and financial objectives.
• Lead internal and external governance meetings, including steering committees and partner collaborations, to ensure alignment and proactive quality management.

Senior Director, Cell Therapy Quality Automation

Mental Health Therapist, LCSW, LICSW, LMHC, MHC, LMFT

Part Time Mental Health Therapist – LCSW, LPC, LMFT

Mental Health Therapist, LCSW, LICSW, LMHC, MHC, LMFT

Mental Health Therapist, LCSW, LICSW, LMHC, MHC, LMFT

Licensed Mental Health Therapist, LCSW, LPC, LMFT