Senior Director, Cell Therapy Quality Automation

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: 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 platformsincluding 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.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. 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.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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