Vice President, GBU Quality

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Position Summary

In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network which includes the biologics & pharma operating units, internally and externally, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of all bio and pharma manufactured commercial products. Responsible for direction of the quality operations teams supporting manufacturing, laboratory operations, and releasing or certifying of all BMS’ products produced, including internal and external manufacturing. 

This role will ensure consistency and alignment in the overall GBU Network Strategy and operational performance. The role will be part of the Global Quality Leadership Team (GQLT), the GBU Leadership Team, and will manage a team of managers, including the Site Quality Heads of internal manufacturing sites, and other Quality Leaders responsible for enabling quality activities critical to compliance and network related projects. This role will require strong collaboration with the Global Manufacturing and Supply Chain functions. 
 

Drive significant impact of current and future business performance and network strategies, through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderate to high complexity quality and compliance responsibilities to ensure quality.  
 

Recognizes the current context of where we are (run the business) and future actions, and ensure the organization can operate in a compliant and effective way to maintain continuity of supply. 

Key Responsibilities

• Supports the development, direction, and execution of the quality strategy for the GBU (Biologics & Pharma) manufacturing organization.  
• Provides leadership direction for a multi-functional group of quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform quality strategy, as well as other senior quality leaders responsible to enable quality activities critical to compliance and network related projects. 
• Ensures that a robust and effective quality management system is implemented according to the global standards, to achieve the quality objectives of the GBU (Biologics & Pharma) Manufacturing operations. 
• Progresses on the suitability and effectiveness of the quality management system and GMP compliance through participation in the required quality management reviews. 
• Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality. 
• Manages/supports the resolution of quality and technical problems within the GBU organization in alignment with global standards, including Internal and external manufacturing. 
• Supports audits and Health Authority inspections for the GBU sites as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines. 
• Assures appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures. 
• Ensures that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System). 
• Provides quality oversight and a