Director, Global Process Owner (GPO) of Event Management & CAPA

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities 1. Business Process Management • Serve as the Global Business Process Owner for Event Management & CAPA, including Deviation and other event management processes. • Define and maintain the global process strategy, vision, objectives, and roadmap aligned with Quality and business priorities. • Establish and maintain global standards, procedures, governance models, and business rules supporting the processes. • Ensure processes comply with global regulatory requirements, quality standards, and business strategies. • Standardize processes, workflows, and practices across sites, functions, and systems. • Define end-to-end process requirements and ensure enabling technologies support effective process execution. • Represent the process in internal and external benchmarking activities to identify best practices and emerging trends. • Advance process maturity and transformation through simplification, innovation, digital enablement, and continuous improvement. 2. Process Governance & Network Leadership • Drive alignment and governance for process changes, strategic initiatives, and business requirements. • Lead global governance forums and networks that support consistent process execution and stakeholder engagement. • Facilitate regular meetings with sub-process and local process owners to drive alignment and information sharing. • Provide upward communication, relevant business needs and escalation of significant process risks or systemic issues through appropriate quality governance structures. • Establish mechanisms to gather stakeholder feedback and incorporate insights into process improvements. • Conduct physical and virtual Gemba engagements across sites and functions to understand process execution, identify pain points, and drive continuous improvement opportunities. • Maintain strong partnerships across Quality, Manufacturing, Development, Supply Chain, Regulatory, and Digital organizations. 3. Performance Monitoring & Data Management • Define and maintain global process performance metrics, key performance indicators (KPIs), and dashboards. • Establish consistent measurement and reporting practices across sites and functions. • Analyze performance trends to identify improvement opportunities, recurring issues, and emerging risks. • Drive data-based decision-making and process optimization. • Manage process-specific data • Present process performance, risks, and improvement opportunities to leadership and governance forums. 5. Continuous Improvement & Transformation • Lead strategic initiatives to improve process effectiveness, efficiency, and user experience. • Facilitate practical problem-solving activities to address process gaps and performance opportunities. • Perform process maturity assessments and develop improvement roadmaps. • Support implementation of automation, analytics, AI-enabled capabilities, and digital solutions that enhance process performance. • Drive adoption of Lean, Operational Excellence, and Business Process Management principles. • Partner with Digital Quality and IT teams to ensure systems evolve in support of business needs. 6. Training, Change Management & Communications • Define, own, and maintain global training content and requirements, curricula, certification requirements, and process documentation. • Develop communication and change management strategies supporting process updates and enhancements. • Ensure consistent deployment and adoption of process changes globally. • Provide coaching, guidance, and subject matter expertise to process owners and stakeholders. • Serve as the primary global subject matter expert for Deviation, CAPA, and Event Management processes. • Ensure key decisions, process updates, and governance outcomes are effectively communicated across the organization. 7. Audit, Inspection & Regulatory Support • Support internal audits, health authority inspections, and inspection readiness activities. • Serve as the process subject matter expert during regulatory inspections and audit engagements. • Monitor regulatory trends, evolving expectations, and industry standards impacting the processes. • Lead process gap assessments and remediation initiatives as needed. • Ensure process documentation, governance, and execution remain aligned with regulatory expectations and industry best practices. 8. Deviation, CAPA & Event Management Strategy • Ensure deviation, CAPA, and event management processes are risk-based, scalable, and effective in identifying, investigating, mitigating, and preventing quality issues. • Drive consistent approaches for issue identification, impact assessment, investigation, root cause analysis, and effectiveness verification. • Monitor process health and ensure systemic issues are identified, escalated, and appropriately addressed. • Champion proactive quality management practices that reduce recurrence and improve organizational learning. • Ensure process design supports inspection readiness and effective management oversight. • Partner with stakeholders to continuously simplify workflows and remove non-value-added activities. Qualifications & Experience Education • Bachelor's degree in Life Sciences, Engineering, Quality, or related discipline required. • Advanced degree (MS, MBA, or PhD) preferred. Experience Required • 12+ years with a BA/BS or 8+ years with Advanced Degree of experience in pharmaceutical/biotech quality systems • Extensive experience in Quality Systems, including Deviation Management, CAPA, Quality Events, Investigations, and Compliance. • Strong understanding of global regulatory requirements (FDA, EMA, ICH) and inspection expectations. Preferred • Demonstrated experience leading global or enterprise-wide business processes in a regulated environment. • Experience leading cross-functional global initiatives. • Certified and/or experienced in various problem-solving techniques (e.g. Fishbone Analysis, Systems Model Application such as HDPI, Lean Six Sigma Green Belt/Black Belt) Leadership Competencies • Strategic Enterprise Leadership – ability to align global processes with business strategy • Systems Thinking – integrates governance, process, data, and behavior into cohesive solutions • Data-Driven Decision Making – leverages analytics to drive proactive quality outcomes • Change Leadership – leads large-scale transformation and organizational adoption • Operational Excellence – focuses on simplification, scalability, and reliability • Influence & Collaboration – effectively leads across complex, matrixed organizations Success Measures • Global process standardization and adoption across sites and functions. • Improved deviation closure cycle times and investigation quality. • Increased CAPA effectiveness and reduction of re