ESOQ Quality Transformation Lead

<p><b>Use Your Power for Purpose</b><br/><span>Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the Director of Quality Assurance within the Global Supply division, you will play a pivotal role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team, fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide.<br/> <br/>The ESOQ Quality Transformation Lead is a senior execution leader responsible for driving complex transformation portfolios that strengthen inspection readiness, compliance, operational excellence, and digital/AI innovation across the External Supply Operations Quality (ESOQ) organization. The role translates strategy into execution through structured program leadership, cross-functional collaboration, and sustainable implementation of new ways of working across a global external supply network.<br/> </span><br/><b>What You Will Achieve</b><br/><span> </span></p><ul><li><p><span>Leading assigned ESOQ transformation programs and workstreams that advance sustainable compliance, inspection readiness, operational excellence, and organizational effectiveness.</span></p></li><li><p><span>Leading inspection readiness activities for assigned scope, including support for external inspections involving CMOs / suppliers and internal inspections, self-inspections, and RQA audit readiness, ensuring robust preparation, coordination, execution support, and follow-up.</span></p></li><li><p><span>Leading and/or coordinating elements of the annual audit and self-inspection planning cycle for assigned areas, including schedule development, readiness tracking, issue remediation, lessons learned, and post-audit / post-inspection follow-up.</span></p></li><li><p><span>Driving the ESOQ Gemba process for assigned scope, ensuring observations, escalations, actions, and learnings are translated into sustainable improvements.</span></p></li><li><p><span>Driving the Quality Revolution agenda through implementation of new ways of working, capability building, stakeholder engagement, and a proactive quality culture.</span></p></li><li><p><span>Driving cross-network learning from inspections, audits, and CAPAs, ensuring observations at one CMO or supplier are assessed for broader applicability and translated into preventive actions across the network to strengthen inspection readiness.</span></p></li><li><p><span>Developing, monitoring, and communicating metrics / KPI reporting that provide visibility to compliance performance, inspection readiness, audit outcomes, remediation progress, and transformation effectiveness.</span></p></li><li><p><span>Driving CAPA closure and effectiveness verification across assigned scope, ensuring clear ownership and accountability across ESOQ, Site QA, and CMO QA</span></p></li><li><p><span>Applying Quality Risk Management principles to identify, assess, prioritize, and mitigate risks associated with compliance, quality systems, business process changes, and transformation initiatives.</span></p></li><li><p><span>Leading continuous improvement initiatives that simplify and strengthen quality processes, governance routines, and inspection readiness practices using lean, risk-based, and data-driven approaches.</span></p></li><li><p><span>Leading or supporting the design and implementation of innovative AI and digital transformation solutions in quality processes, ensuring alignment with regulatory expectations, data integrity principles, and business value objectives.</span></p></li><li><p><span>Partnering with ESOQ leadership and cross-functional stakeholders to assess readiness, manage impacts, and drive sustainable adoption of transformation initiatives.</span></p></li><li><p><span>Develop and execute integrated change, communication, and training strategies to support adoption of new ways of working, ensuring alignment across global stakeholders and reinforcement of desired behaviors and mindset.</span></p></li><li><p><span>Leading governance routines, milestone tracking, issue and risk management, and execution reporting for assigned programs or project portfolios.</span></p></li><li><p><span>Supporting audit and inspection response activities, including readiness reviews, management reporting, CAPA follow-up, trend analysis, and continuous learning.</span></p></li><li><p><span>Benchmarking internally and externally