Executive Director, Head of Quality, Cell Therapy Manufacturing Facility

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.

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Position: Executive Director, Head of Quality, Cell Therapy Manufacturing Facility
Location: Summit, NJ

Position Summary
BMS Cell Therapy Quality Operations is seeking a Head of Quality at the Cell Therapy Manufacturing Facility in Summit, New Jersey (USA). This role will be responsible for leading the day-to-day Quality operations at the Cell Therapy site including Quality Control, Quality Assurance Operations, and Quality Systems and Compliance. The role will also be a key contributor to the implementation, execution and monitoring of BMS’s quality systems in support of manufacturing, testing and release of BMS’s commercialized Cell Therapy products. This includes but not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. The role is also responsible for the operational improvement within the Site Quality team of product quality, GMP compliance, vein-to-vein delivery time, and process efficiency through application of operational excellence, risk management, and knowledge transfer principles.

This individual will be a key leader in the Global Cell Therapy Drug Product Quality organization and a champion for quality principles and compliance within the Summit Cell Therapy Facility organization. This individual will be a member of the Manufacturing Leadership Team in Summit in addition to the Global Cell Therapy Drug Product Quality Leadership Team. This role is stationed in Summit, NJ and reports to the Vice President, Cell Therapy Drug Product Quality.

Key Responsibilities
• Responsible for the Quality oversight of GMP operations at the Cell Therapy manufacturing facility, and ensuring adherence to applicable GMP regulations, company policies and procedures
• Assure the required processes, procedures, systems and resources are in place to ensure compliant
and efficient disposition of materials and cell therapy products

• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system
• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel
• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
• Lead the implementation of BMS’s inspection readiness program at the facility
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the facility
• Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.)
• Develop departmental contributions, goals and objectives to ensure timely completion of all deliverables
• Champion and foster a positive and quality compliance culture
• Establish and effectively manage the Cell Therapy Quality annual operating budget
• Represent and lead Cell Therapy Quality in the development of corporate initiatives and planning

Qualifications & Experience
• BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions
• Expertise in GMP compliance and global, local and US/EU regulations
• Experience in hosting global regulatory agency inspections and successfully presenting prod