Vice President, Corporate Quality

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

The Vice President, Corporate Quality will provide strategic quality and compliance leadership in the GxP* development and implementation of an integrated Quality Management System (QMS) across the Enterprise inclusive of Research & Early Development, Global Drug Development, Global Product and & Supply and Medical Affairs and in support of the product lifecycle.

The QMS must ensure that its effectiveness and efficiency from a performance perspective is managed and continuously improving to maintain compliance to current and evolving global regulatory requirements and regulations and in keeping with external industry trends inclusive or audit, inspection and KPI measurements.

Design and implement internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level. Actively engage with regulators and industry peers in industry associations, working groups, etc. representing BMS strategic initiatives and input.

Key oversight of regulatory communications including FARs, BPDRs, DPRs, etc.

• GxP is inclusive of Good Clinical Practices, Good Pharmacovigilance Practices, Good Laboratory Practices, Good Manufacturing and Good Distribution Practices supporting the development and commercialization of drugs, biologics, medical devices and Cart-T.

Key Responsibilities

• Represents BMS across industry and regulatory QMS forums to drive/leverage best practices, share knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS.
• Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMSLT, CEO and BoD at the request and direction of CQO.
• Chairs the QMS Governance Forum responsible for overseeing the QMS operating model.
• Proactive analysis of adherence to QMS through risk based internal audits, monitoring and management of regulatory inspections and assimilation of global metrics and oversight of Quality Councils
• Establish a single, integrated Quality Management System across the product lifecycle with a process-centric orientation such that continuous improvement remains central to building and sustaining an effective QMS long term. Build and develop a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPS and Commercial.
• Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS.
• In collaboration with the Quality Leadership Team, ensures that measurement systems are in place and actively monitoring for corrective and preventative actions to drive continuous Improvement for the integrated GxP QMS.

Qualifications & Experience

• Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.
• In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees.
• Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality.
• Experience with managing a large budget.
• Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience.
• Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies.
• Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations.
• Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices).
• Experience in leading a major quality discipline with GxP quality experience.
• Position may require 20-30% travel on occasion.
• International regulatory experience in GxP environment.
• Previous experience dealing with FDA and other major regulatory agencies.
• Managed a large global operation involving diverse cultures and employees.

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

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

To 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 [email protected]. 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.