Vice President, Corporate Quality

Role Summary

This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities.

Responsibilities

• Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement.
• Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial.
• Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance).
• Designs and implements 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. working groups, etc. representing BMS strategic initiatives and input.
• 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 BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO.
• 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.
• Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit.
• Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc.
• Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS.
• Chairs the QMS Governance Forum responsible for overseeing the QMS operating model.
• Builds and continuously develops a high-performing global Quality team.
• Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise.

Qualifications

• Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience.
• B achelor of Science in relevant Science ( e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred
• Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies.
• Experience in leading a major quality discipline with GxP quality experience.
• Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices).
• International regulatory experience in GxP environment.
• Previous proven experience dealing with FDA and other major regulatory agencies.
• Experience with digital innovation, including automation and Artificial Intelligence capabilities.
• Managed a large global operation involving diverse cultures and employees.
• 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.
• Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations.
• Experience with managing a large budget.
• Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality.
• Position may require 20-30% travel on occasion.