Bristol Myers Squibb
Vice President, R&D Quality
Bristol Myers Squibb, Summit, New Jersey, us, 07902
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.
Position Summary
This role is the senior Quality executive for all R&D related activities covering pre-clinical, product and clinical development, and Pharmacovigilance. This position is also a senior member of the Global Quality Leadership Team (GQLT). The incumbent will provide oversight of GLP, GCP and GPvP audits; manage regulatory / health authority inspections for BMS and third parties where necessary; enhance focus on R&D Quality QMS and remediation across enterprise and provide key interface with R&ED (Research and Early development)/ GDD (Global Drug Development) and Global Medical groups; and represent BMS as senior Quality executive to health authorities. They will also provide leadership to the GxP QMS with focus on clinical and medical QMS management and act as a key contributor to GQLT in advancing new integrated Quality vision and strategy and ongoing Global Quality talent development.
Key Responsibilities
Provide leadership and expertise on the strategy, activities and actions necessary to ensure that R&ED, GDD, Global Medical and PD groups are operating in full compliance with sound scientific practice, as well as current GLP, GCP, GCLP, GPvP, and GDP as applicable, and other applicable regulations and departmental procedures.Provide strategic and operational leadership of the Clinical Trial & Safety, Quality Lab Practices, and Pharmacovigilance groups. This position is responsible for the quality governance and management of these groups at BMS.Develop and implement a Quality culture and culture of continuous improvement across the R&ED, GDD, Global Medical and PD stakeholders.Provide input into development strategies to support innovation, achieve business objectives, and maintain GxP compliance.Provide leadership and direct oversight of R&ED/GDD and PD remediation efforts.Represent BMS as senior Quality executive for key interactions with health authorities worldwide.Represent R&D Quality at BMSLT Quarterly Quality reviews.Qualifications & Experience
Minimum of BA/BS degree or in a life science discipline; advanced education preferred.Minimum of 20 years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Demonstrated track record in Quality related disciplines.Experience in leading a major quality discipline with GxP quality experience.International regulatory experience in GMP environment.Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies.Previous experience dealing with FDA and other major regulatory agencies in regulatory authority inspections, investigations, and audits and senior executive interactions with health authorities.Proven leadership track record of developing talent, driving change and challenging the status quo.Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.In-depth experience in managing senior teams, and in providing coaching, development and mentoring to employees.Understands the big picture, beyond their own functional area. Enterprise thinker.Leads within the broader internal and external network and seeks to have impact on organization-wide performance.Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making.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 plans for the organization.Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.
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Position Summary
This role is the senior Quality executive for all R&D related activities covering pre-clinical, product and clinical development, and Pharmacovigilance. This position is also a senior member of the Global Quality Leadership Team (GQLT). The incumbent will provide oversight of GLP, GCP and GPvP audits; manage regulatory / health authority inspections for BMS and third parties where necessary; enhance focus on R&D Quality QMS and remediation across enterprise and provide key interface with R&ED (Research and Early development)/ GDD (Global Drug Development) and Global Medical groups; and represent BMS as senior Quality executive to health authorities. They will also provide leadership to the GxP QMS with focus on clinical and medical QMS management and act as a key contributor to GQLT in advancing new integrated Quality vision and strategy and ongoing Global Quality talent development.
Key Responsibilities
Provide leadership and expertise on the strategy, activities and actions necessary to ensure that R&ED, GDD, Global Medical and PD groups are operating in full compliance with sound scientific practice, as well as current GLP, GCP, GCLP, GPvP, and GDP as applicable, and other applicable regulations and departmental procedures.Provide strategic and operational leadership of the Clinical Trial & Safety, Quality Lab Practices, and Pharmacovigilance groups. This position is responsible for the quality governance and management of these groups at BMS.Develop and implement a Quality culture and culture of continuous improvement across the R&ED, GDD, Global Medical and PD stakeholders.Provide input into development strategies to support innovation, achieve business objectives, and maintain GxP compliance.Provide leadership and direct oversight of R&ED/GDD and PD remediation efforts.Represent BMS as senior Quality executive for key interactions with health authorities worldwide.Represent R&D Quality at BMSLT Quarterly Quality reviews.Qualifications & Experience
Minimum of BA/BS degree or in a life science discipline; advanced education preferred.Minimum of 20 years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Demonstrated track record in Quality related disciplines.Experience in leading a major quality discipline with GxP quality experience.International regulatory experience in GMP environment.Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies.Previous experience dealing with FDA and other major regulatory agencies in regulatory authority inspections, investigations, and audits and senior executive interactions with health authorities.Proven leadership track record of developing talent, driving change and challenging the status quo.Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.In-depth experience in managing senior teams, and in providing coaching, development and mentoring to employees.Understands the big picture, beyond their own functional area. Enterprise thinker.Leads within the broader internal and external network and seeks to have impact on organization-wide performance.Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making.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 plans for the organization.Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.
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