Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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careers.Bms.Com/working-with-us Position SummaryThis 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.
Manages regulatory / health authority inspections for BMS and third parties where necessary.
Enhances 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.
Represents BMS as senior Quality executive to health authorities.
Provides leadership to the GxP QMS with focus on clinical and medical QMS management.
Acts as a key contributor to GQLT in advancing new integrated Quality vision and strategy and on-going Global Quality talent development.
Key ResponsibilitiesProvide 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 & ExperienceMinimum of BA/BS degree or in a life science discipline; advanced education preferredMinimum 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 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.
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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
COVID-19 InformationTo protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S.
and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.
Therefore, all BMS applicants seeking a role located in the U.S.
and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana.
This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. BristolMyersSquibb BoudryNeuchâtel
