Bristol Myers Squibb
Senior Director, Cell Therapy Quality Automation
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Director, Cell Therapy Quality Automation
Position Summary
The Senior Director of Cell Therapy Quality Automation Services will report to the Executive Director of Cell Therapy Global Product Quality and serve as a key leader within the GCTQ Organization. This role will lead a global team of quality professionals focused on ensuring the highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and release. The Senior Director will play an integral role in supporting the implementation of advanced manufacturing, testing and quality systems platforms-including the Automated Manufacturing System (AMS), Automated Quality Control (AQC) system, Gene Delivery Manufacturing/Testing, Quality Management Systems (QMS), and Planning, Scheduling, Warehouse & Logistics workstreams.
Key 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 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.
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.
Basic 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.
Preferred Qualifications
Experience with autologous CAR T cell therapy, viral vector manufacturing, and quality control equipment/system automation.
Track record supporting product launches, BLA submissions, and regulatory interactions for advanced cell and gene therapies.
Combination of experience in quality assurance, quality control, and compliance for process development, MS&T, and external manufacturing.
Compensation Overview
Devens - MA - US $238,270 - $288,730
Madison - Giralda - NJ - US $222,680 - $269,839
Seattle - WA $244,950 - $296,825
Benefits and Legal Statements
Medical, pharmacy, dental and vision care; wellbeing support; financial protection benefits; paid time off; parental and caregiver leave; and other perks such as tuition reimbursement.
Equal employment opportunity and accessibility statement provided at
https://careers.bms.com/eeo-accessibility .
COVID‑19 vaccination is strongly recommended for all employees.
We encourage you to apply even if your experience does not fully match the requirements. This opportunity may transform your career and life.
#J-18808-Ljbffr
Key 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 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.
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.
Basic 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.
Preferred Qualifications
Experience with autologous CAR T cell therapy, viral vector manufacturing, and quality control equipment/system automation.
Track record supporting product launches, BLA submissions, and regulatory interactions for advanced cell and gene therapies.
Combination of experience in quality assurance, quality control, and compliance for process development, MS&T, and external manufacturing.
Compensation Overview
Devens - MA - US $238,270 - $288,730
Madison - Giralda - NJ - US $222,680 - $269,839
Seattle - WA $244,950 - $296,825
Benefits and Legal Statements
Medical, pharmacy, dental and vision care; wellbeing support; financial protection benefits; paid time off; parental and caregiver leave; and other perks such as tuition reimbursement.
Equal employment opportunity and accessibility statement provided at
https://careers.bms.com/eeo-accessibility .
COVID‑19 vaccination is strongly recommended for all employees.
We encourage you to apply even if your experience does not fully match the requirements. This opportunity may transform your career and life.
#J-18808-Ljbffr