Vice President, R&D Quality - Bristol Myers Squibb
Summit, NJ
About the Job
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 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 .
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 healthy 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 on-going 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.
+ Provides leadership and direct oversight of R&ED/GDD and PD remediation efforts.
+ Represent BMS as senior Quality executive for key interactions with healthy authorities worldwide.
+ Represents R&D Quality at BMSLT Quarterly Quality reviews.
+ BMSLT Quality executive for key interactions with health authorities worldwide.
Qualifications & Experience
+ Minimum of BA/BS degree or in a life science discipline; advanced education preferred
+ Minimum of 15 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.
#LI-HYBRID
If you come across a role that intrigues you but doesn't 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.
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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585970
Updated: 2024-10-04 03:11:07.726 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 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 .
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 healthy 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 on-going 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.
+ Provides leadership and direct oversight of R&ED/GDD and PD remediation efforts.
+ Represent BMS as senior Quality executive for key interactions with healthy authorities worldwide.
+ Represents R&D Quality at BMSLT Quarterly Quality reviews.
+ BMSLT Quality executive for key interactions with health authorities worldwide.
Qualifications & Experience
+ Minimum of BA/BS degree or in a life science discipline; advanced education preferred
+ Minimum of 15 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.
#LI-HYBRID
If you come across a role that intrigues you but doesn't 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.
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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585970
Updated: 2024-10-04 03:11:07.726 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb