Vice President, R&d Quality - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Boudry, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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.

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. 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 healthy 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 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.
Indepth 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 organizationwide performance.
Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making
Shares resources and makes difficult tradeoffs 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 risktaking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

LI-HYBRID

Uniquely Interesting Work, Life-changing Careers

On-site Protocol

Physical 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 Information