Executive Director, GxP Quality Center of Excellence

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Summary The Executive Director, GxP Center of Excellence (CoE) reports into VP, R&D Quality. It is a strategic leadership role responsible for establishing and leading an enterprise-wide GxP (GCP, GLP and GVP) quality capability that drives consistent, data driven, risk-ballanced practices and inspection readiness across R&D and associated functions. This role integrates vendor quality, device quality, GxP inspections, CAPA and Investigation Excellence, business development (M&A), governance, QMS, project management, training and knowledge management into a unified CoE operating model.The leader will ensure quality by design, proactive risk management, and regulatory compliance while enabling innovation, speed, and scalable growth across the portfolio. Through active participation in relevant governance forums, this role oversees the identification, escalation, and mitigation of quality and compliance risks while driving continuous improvement, operational effectiveness, inspection readiness, and quality culture. The leader champions enterprise-wide quality transformation, leveraging data-driven insights, digital innovation, and cross-functional collaboration to strengthen compliance, enhance organizational capabilities, and enable the efficient delivery of medicines to patients.The leader establishes and evolves the strategic vision, roadmap, and operating model for key quality capabilities with the CoE. Through continuous improvement, digital innovation, and operational excellence, this role builds future-ready capabilities that strengthen compliance, enhance organizational effectiveness, and accelerate the delivery of innovative therapies to patients. Key Responsibilities Enterprise GxP CoE Leadership Define and operationalize the GxP CoE strategy, aligned to enterprise objectives (People, Performance, Pipeline and Innovation). Establish a centralized capability model that standardizes best practices, tools, and frameworks across R&D Quality. Provide leadership in embedding proactive, risk-based quality engineering, compliance, and lifecycle management from concept through post-market surveillance, ensuring patient safety, regulatory compliance, and product quality throughout the end-to-end product lifecycle. Drive a risk-balanced, data-driven quality culture across all GxP domains. Partner with R&D, Product Development, Regulatory, Medical, Technology, Operations, and Global Quality stakeholders to proactively identify, assess, and mitigate quality and compliance risks across combination products, diagnostics, and digital health technologies. Drive digital transformation to strengthen compliance, streamline operating model and improve business outcomes Drive enterprise-wide quality excellence by embedding Quality by Design (QbD), risk-based decision making, lifecycle management, and continuous improvement principles Champion a right-first-time quality culture and continuous improvement mindset across the enterprise. Partner with RDQ pillars and relevant stakeholders to assure state of audit and inspection readiness and provide input into audit and inspection strategy and execution Inspection Management and Readiness Provide strategic leadership and enterprise oversight for global inspection management and regulatory readiness, ensuring a proactive, risk-based approach to compliance, health authority engagement, and sustained inspection excellence across the R&D portfolio. Lead the development and execution of global inspection strategies across GCP, GVP, and GLP, including: Sponsor inspections Investigator site inspection oversight Global GLP inspections Safety surveillance inspections Pharmacovigilance system inspections Affiliate and local authority inspections Post-marketing lifecycle inspections Regulatory authority engagements (FDA, EMA, PMDA, NMPA, MHRA, and other global agencies) Establish and maintain a state of continuous inspection readiness through integrated risk assessment, quality intelligence, preparedness programs, and proactive identification of emerging compliance risks. Oversee inspection response governance, ensuring timely, consistent, and high-quality interactions with regulatory authorities, including inspection preparation, response strategy, and commitment management. Provide executive oversight of inspection observations, CAPAs, effectiveness evaluations, and systemic remediation efforts to ensure sustainable compliance and continuous improvement. Partner with senior leaders across Research, Drug Development, Global Quality, and functional teams to drive accountability, strengthen inspection preparedness, and ensure end-to-end ownership of inspection outcomes. Leverage inspection intelligence, regulatory trends, and cross-industry learnings to identify enterprise risks, inform strategic decisions, and enhance organizational readiness. Define and advance a future-focused inspection operating model utilizing digital capabilities, advanced analytics, AI-enabled solutions, and innovative approaches to improve efficiency, scalability, and regulatory compliance across the global portfolio Vendor Quality Oversight Establish and drive an end-to-end GxP vendor quality oversight framework, including qualification support, quality oversight, performance monitoring, and risk management Ensure consistent application of GxP expectations across service providers, CROs, CMOs, labs, and strategic partners Deliver vendor risk segmentation, KPIs/KQIs, and governance mechanisms to proactively mitigate quality risks and improve quality/compliance. Support and partner across RDQ pillars in inspection readiness and audit readiness for all vendors Provide leadership to Quality Investigations, Root Cause Analysis (RCA) and CAPA management for internal quality events and oversight of external quality events Device Quality Integration Drive a data-driven, innovative organization that simplifies complexity, accelerates the device, IVD and digital health pipeline, and builds a culture where quality enables speed and fit-for-purpose compliance Drive the enterprise quality strategy, governance, and oversight for combination products, diagnostics, and digital health technologies across BMS, partnering with key stakeholders Provide strategic quality leadership and oversight for combination products, on-body delivery system (OBDS) platforms etc., ensuring robust design controls, human factors engineering (HFE), risk management, supplier quality, and post-market surveillance throughout the product lifecycle Provide leadership in development and execution of quality strategies for in vitro diagnostics (IVD), including oversight of CLIA/CAP laboratory quality systems, assay development and transfer, analytical validation, and diagnostic supplier quality management to ensure regulatory compliance and data integrity Represent Quality in governance forums and regulatory interactions, providing strategic guidance on complex quality, compliance, product stewardship, and patient safety matters related to devices, diagnostics, and digital health solutions. Continuously monitor evolving industry standards, regulatory expectations (e.g., FDA, EU MDR/IVDR/CDx etc.), and technology trends to develop future-ready quality capabilities that support innovation while maintaining the highest standards of quality, compliance, and patient trust Standardize device quality processes, design