Bristol-Myers Squibb
Head of QA Technical Operations
Bristol-Myers Squibb, Gray Summit, Missouri, United States, 62407
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. Read more: careers.bms.com/working-with-us.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Position:
Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing
Shift Available:
Monday - Friday, Hybrid Day Shift
Responsibilities:
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, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
Strategically identifies, implements, and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
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 the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive, and constructive feedback and training.
Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
Acts as subject matter expert for GMP operations during audits and regulatory inspections. Contributes to the development and execution of the S12 inspection readiness plan. Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.
Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring, and developing personnel.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit S12 facility.
Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.
Knowledge & Skills:
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
Proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Leads within the broader internal and external network and seeks to have an impact on organization-wide performance.
Embraces complexity but strives for simplicity.
Shares resources and makes difficult trade-offs to benefit the organization at large.
Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
Translates the case for change into actionable and strategic plans for the organization.
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) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products.
Demonstrated experience building and leading exceptional teams.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
Strong presentation and visual management capability.
Knowledge of performance measurement tools and metrics.
Good facilitation, change management, interpersonal and problem-solving skills.
Preferred Requirements:
Background in Biologics or Cell Therapy Manufacturing is preferred.
Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred.
Experience in management of large teams, including direct and indirect reports.
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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: careers.bms.com/working-with-us.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Position:
Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing
Shift Available:
Monday - Friday, Hybrid Day Shift
Responsibilities:
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, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
Strategically identifies, implements, and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
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 the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive, and constructive feedback and training.
Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
Acts as subject matter expert for GMP operations during audits and regulatory inspections. Contributes to the development and execution of the S12 inspection readiness plan. Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.
Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring, and developing personnel.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit S12 facility.
Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.
Knowledge & Skills:
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
Proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Leads within the broader internal and external network and seeks to have an impact on organization-wide performance.
Embraces complexity but strives for simplicity.
Shares resources and makes difficult trade-offs to benefit the organization at large.
Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
Translates the case for change into actionable and strategic plans for the organization.
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) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products.
Demonstrated experience building and leading exceptional teams.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
Strong presentation and visual management capability.
Knowledge of performance measurement tools and metrics.
Good facilitation, change management, interpersonal and problem-solving skills.
Preferred Requirements:
Background in Biologics or Cell Therapy Manufacturing is preferred.
Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred.
Experience in management of large teams, including direct and indirect reports.
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