Bristol-Myers Squibb
Head of QA Technical Operations
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
Head of QA Technical Operations
Working with UsChallenging. 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 rich in diversity. 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.The Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Sr. Director, Quality Technical Operations will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing at Summit, and is as a champion for quality principles and compliance within the organization.Shift Available:Monday - Friday, Hybrid Day ShiftResponsibilities:Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12). Drives for operational adherence to applicable cGMP regulations, BMS policies and procedures.Provides direction to Operations, Facilities, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors.Strategically identifies, implements, and leads site-wide QA transformational programs and strategies.Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.Ensures the required processes, procedures, systems, and resources are in place to enable compliant manufacturing of CAR T products.Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and associated risk management control strategy.Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor.Acts as subject matter expert for GMP operations during audits and regulatory inspections.Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture and drives a high-performing team.Provides leadership and builds an exceptional team to manage QA functions.Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.Knowledge & Skills:Ability to build strong, trusting relationships and work across divisions.Excellent communication and interpersonal skills.Strategic thinker with high business acumen.Excellent influencing and negotiating experience.Proven track record of delivering results.Adapts to changing work environments and organizational needs.Creates a vision for the future by spotting strategic opportunities.Basic Requirements:Bachelor’s degree in relevant Science or Engineering discipline.15+ years of experience in managing Quality Assurance function.At least 7 years of people management experience.Expertise in Good Manufacturing Practices (GMP).Experience with implementing and overseeing GMP operations.Demonstrated experience building and leading exceptional teams.Strong presentation and visual management capability.Preferred Requirements:Background in Biologics or Cell Therapy Manufacturing.Expert-level expertise in Pharmaceutical Quality Management or Lean Six Sigma.BMSCART, #LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.Uniquely Interesting Work, Life-changing CareersWith 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.
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Working with UsChallenging. 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 rich in diversity. 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.The Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Sr. Director, Quality Technical Operations will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing at Summit, and is as a champion for quality principles and compliance within the organization.Shift Available:Monday - Friday, Hybrid Day ShiftResponsibilities:Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12). Drives for operational adherence to applicable cGMP regulations, BMS policies and procedures.Provides direction to Operations, Facilities, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors.Strategically identifies, implements, and leads site-wide QA transformational programs and strategies.Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.Ensures the required processes, procedures, systems, and resources are in place to enable compliant manufacturing of CAR T products.Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and associated risk management control strategy.Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor.Acts as subject matter expert for GMP operations during audits and regulatory inspections.Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture and drives a high-performing team.Provides leadership and builds an exceptional team to manage QA functions.Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.Knowledge & Skills:Ability to build strong, trusting relationships and work across divisions.Excellent communication and interpersonal skills.Strategic thinker with high business acumen.Excellent influencing and negotiating experience.Proven track record of delivering results.Adapts to changing work environments and organizational needs.Creates a vision for the future by spotting strategic opportunities.Basic Requirements:Bachelor’s degree in relevant Science or Engineering discipline.15+ years of experience in managing Quality Assurance function.At least 7 years of people management experience.Expertise in Good Manufacturing Practices (GMP).Experience with implementing and overseeing GMP operations.Demonstrated experience building and leading exceptional teams.Strong presentation and visual management capability.Preferred Requirements:Background in Biologics or Cell Therapy Manufacturing.Expert-level expertise in Pharmaceutical Quality Management or Lean Six Sigma.BMSCART, #LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.Uniquely Interesting Work, Life-changing CareersWith 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.
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