Senior Director, Cell Therapy Quality Automation

Role Summary

The Senior Director of Cell Therapy Quality Automation Services will lead a global quality organization focused on ensuring cGMP compliance, product quality, and regulatory readiness as Bristol Myers Squibb automates Cell Therapy manufacturing, testing and release. This role oversees implementation of advanced manufacturing, testing and quality systems platforms including AMS, AQC, gene delivery manufacturing/testing, QMS, and planning, scheduling, warehouse & logistics workstreams.

Responsibilities

• 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 GMP qualification, validation, and routine operation.
• Partner 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 QMS initiatives.
• Partner with global Quality automation initiatives and advocate for cell therapy innovations.
• 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.

Qualifications

• BS, MS, or PhD in Life Sciences (Biology, Chemistry, Engineering) or related field with 12+ years of experience in GMP Quality, with 7+ years in people management, and 5+ years supporting cell therapy, gene therapy, or advanced biologics manufacturing.
• Demonstrated experience leading global quality teams in a matrixed environment, with a track record of hiring, coaching, and developing technical talent.
• Deep knowledge of cGMP compliance, regulatory requirements, and quality systems in cell and gene therapy manufacturing, including AMS, LIMS, MES, and digitized quality platforms.
• Proven ability to lead quality support for process development, MS&T, and external manufacturing initiatives.
• Strategic thinker with strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with an ability to interact effectively at all levels of the organization and with external partners.
• Experience supporting technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
• Ability to work in a fast-paced environment, balancing agility with robust compliance and quality oversight.
• Experience driving continuous improvement and supporting business process digitization within quality operations.

Skills

• Quality strategy development
• GMP compliance and regulatory readiness
• Automation and digitized quality platforms (AMS, AQC, LIMS, MES)
• Cross-functional collaboration
• Change management and CAPA
• Regulatory submissions and inspections
• Process development support and technology transfers

Education

• BS, MS, or PhD in Life Sciences or related field