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 controls, and lifecycle management practices

Business Development (M&A) Quality

• Partner with Global Quality (GQ) and R&D stakeholders to provide input and GxP quality support for Business Development, Licensing, and M&A activities

• Define and execute GCP/GLP/GVP due diligence frameworks to assess quality risks, compliance posture, and integration complexity

• Provide clear risk assessments and mitigation strategies to inform deal decisions

• Provide leadership for post-deal integration of QMS, processes, and governance structures

• Create necessary playbook, tools and templates to drive business success and sustainable operating framework

Governance & Quality Risk Management

• Establish and maintain robust governance frameworks to ensure consistent oversight, escalation, and decision-making

• Act as Operational Lead for R&D Quality Council and support Enterprise Quality Council content generation

• Drive and support relevant governance councils including vendor quality councils and Joint Operational councils

• Drive cross-functional alignment through quality councils, review boards, and escalation forums

• Define clear roles, responsibilities, and accountability across quality and business stakeholders

• Ensure transparency through standardized metrics, dashboards, and reporting

• Act as the GCP serious breach committee chair and provide leadership to related meetings and decisions

• Define relevant KPIs/KQIs as it pertains to assuring state of compliance and continupus improvement

• Provide strategic leadership and governance for R&D Quality Risk Management, partnering across RDQ, Global Quality, and Drug Development

• Performance trend and signal detection for significant quality events, investigations, serious non-compliance, Serious Breaches, and CAPA management, ensuring timely resolution, sustainable corrective actions, and effective regulatory engagement

• Drive continuous improvement of quality systems, risk management frameworks, and governance processes to enhance inspection readiness, compliance performance, and organizational effectiveness across R&D

Quality Management System (QMS) Excellence, Training & Knowledge Management

• Provide leadership to the design, implementation, and continuous improvement of a modern, harmonized R&D QMS.

• Ensure alignment with global regulatory standards (e.g., Pearl process, ICH E6(R3), GxP regulations etc.)

• In partnership with relevant stakeholders, drive simplification, digitization, and scalability of QMS processes

• Provide effective management of deviations, CAPAs, change control, and quality events with a focus on root cause and prevention

• Establish a future-ready training and capability development strategy aligned to GxP requirements and evolving regulatory expectations

• Compliance oversight for R&D role-based training frameworks using relevant KPIs

• Implement knowledge management systems to enable reuse of best practices, lessons learned, and inspection insights

• Foster a continuous learning culture across R&D teams

CAPA and Investigation Excellence

• Provide vision and define the global CAPA strategy and governance model for Research & Development by establishing standard methods, templates, taxonomies, and escalation pathways for quality events, audits/inspections, and significant non-compliances

• Design and implement a global CAPA governance framework aligned with regulatory expectations and internal quality standards

• Partner with RDQ Global Capability Center Lead, in assuring CAPA-related performance metrics under GCC’s responsibility are effectively managed

• Partners with key stakeholders across BMS, including Senior Vice Presidents / Vice Presidents within Research, Drug Development and Quality functions to influence stakeholders, drive accountability and CAPA ownership at all levels

• Oversee the identification, documentation, and reporting of serious breaches in compliance with regulatory requirements and company policies, ensuring timely and accurate communication to relevant authorities and stakeholders

Project Management

• Lead and drive RDQ strategic projects from initiation through execution, ensuring alignment with BMS/GQ priorities, timelines, budget and measurable outcome

• Partner with GQ and R&D business functions to ensure alignment of strategic priorities and delivery to drive corporate goals

• Support budget management, tiered management and relevant implementation of lean management principles for RDQ.

People Leadership & Organizational Development

• Provides leadership, coaching, and development for direct reports, building organizational capability and cultivating a high-performing team aligned with strategic objectives.

• Build team capability through coaching, performance management, and career development planning.

• Model and reinforce a culture of quality, accountability, and psychological safety.

• Attract and retain top quality talent; resource the TA Quality function appropriately to meet portfolio demands.

• Foster a collaborative, cross-functional partnership mindset within the quality team.

• Represent BMS at external and cross-industry bodies.

• Drive cross-functional collaboration and break down silos across R&D, PDS, and external partners.

• Budget Management for team and RDQ when applicable.

Core Competencies

• Strategic and enterprise mindset

• Risk-based decisi