Bristol Myers Squibb
Senior Director, Cell Therapy Quality Automation
Bristol Myers Squibb, Seattle, Washington, us, 98127
Senior Director, Cell Therapy Quality Automation
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Senior Director, Cell Therapy Quality Automation
role at
Bristol Myers Squibb
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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
Medical, pharmacy, dental and vision care Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
Financial well‑being resources and a 401(k) plan
Short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection, and survivor support
Parental, caregiver, bereavement, and military leave
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
Other perks like tuition reimbursement and a recognition program
Equal Employment Opportunity BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Legal Notice Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Senior Director, Cell Therapy Quality Automation
role at
Bristol Myers Squibb
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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
Medical, pharmacy, dental and vision care Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
Financial well‑being resources and a 401(k) plan
Short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection, and survivor support
Parental, caregiver, bereavement, and military leave
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
Other perks like tuition reimbursement and a recognition program
Equal Employment Opportunity BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Legal Notice Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr