Director, Modality Excellence - Indirect Processes, Quality, Engineering & Maintenance and Warehouse
PharmaBiotechMedTechQuality Assurancecroraveinform
Job description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role As Director, Modality Excellence, you will define, codify and deploy global excellence standards for indirect and enabling processes that influence manufacturing performance, quality flow, cost, capacity, service and reliability. Based in a manufacturing or hub site, you will join GSQ’s Transformation Office and report to the Head of Value Stream Transformation. As a senior individual contributor and global process authority, you will work across Site Leadership, Quality, Engineering, Maintenance, Warehouse, Supply Chain, Finance, Manufacturing Science, Digital and Transformation Office teams. Your scope will cover indirect processes and Quality operations—including deviations, CAPA, change controls, investigations, documentation workflows, QA review loops, batch record support, QA on-the-floor interactions, planning and administrative workflows—as well as Engineering and Maintenance activities, including work orders, preventive and corrective maintenance, planning and scheduling, reliability routines, spare parts, calibration, utilities and technical services. You will also oversee Warehouse and Material Flow processes, including receiving, put-away, picking, staging, kitting, line replenishment, inventory counting, material transport, returns, waste flows and warehouse administration. You will own the lifecycle of standard work, KPI definitions, performance standards, maturity models, diagnostics, cost optimization logic, benchmarking, deployment playbooks and continuous improvement across the network. Your objective will be to establish a repeatable Operating System model that sites can adopt, sustain and continuously improve, rather than delivering isolated improvement projects. Success will be measured through consistent standard-work adoption, stronger KPI performance, reduced indirect labor intensity, improved quality-process flow, higher maintenance productivity, increased asset availability, better warehouse productivity and measurable cost reduction. Please note this role is anticipated for a period of 2 years. How you will contribute: Reporting to the Transformation Office Head, your responsibilities are to Define the Operating System elements for each modality, including standard work, KPI architecture, performance standards, maturity models, diagnostics, hypothesis trees, process-confirmation checklists and A3 problem-solving logic. Translate internal best practices, external benchmarks and site learning into simple, scalable and measurable standards that are practical, auditable, teachable and connected to cost, service, quality, compliance, productivity and capacity outcomes. Establish standard work for roles, handoffs, work content, decision points, required data, visual controls and escalation routines. Codify the best-known way of working for deviations, CAPA, change controls, investigations, maintenance execution, warehouse activities and other recurring processes. Use AVIX or equivalent tools to analyze work content, compare current and target work design, identify non-value-added effort and establish standard time or effort expectations where appropriate. Link standard work to process confirmation and leader standard work to sustain adoption. Define global KPI hierarchies from enterprise outcomes through site, area and process-level indicators. Clarify KPI calculation logic, data sources, review frequency, ownership, target-setting methods and escalation thresholds. Set benchmarks for cycle time, productivity, backlog, schedule adherence, flow efficiency, right-first-time, service level, asset availability, inventory accuracy and cost. Embed KPIs into LPMS or equivalent daily, weekly and monthly performance routines. Identify and quantify opportunities related to indirect labor productivity, process simplification, Quality workflow efficiency, maintenance productivity, warehouse performance, inventory reduction, contractor efficiency and automation. Use AVIX, LPMS data and AI-enabled analytics to identify cost drivers, bottlenecks, repetitive losses, performance gaps and improvement opportunities. Build value cases linking standard work and KPI improvement to cost, capacity, quality, service and reliability outcomes. Track benefit realization and ensure improvements are sustained through management routines and performance standards. Identify practical AI, digital and analytics applications for workflow triage, deviation and CAPA pattern detection, maintenance prediction, workload balancing, anomaly detection, KPI narrative generation and opportunity identification. Partner with Digital, Quality, Compliance and site teams to translate these solutions into operating standards, clear decision rights and adoption routines. Promote responsible and compliant AI use in GxP and Quality-related workflows. Lead site diagnostics, design sprints, Kaizen events and deployment activities in real operating environments. Coach site teams and functional leaders in standard work, KPI management, LPMS routines, AVIX analysis and structured problem solving. Develop playbooks, training materials, process-confirmation guides and communities of practice. Build local champions who can sustain and continuously improve the standards. Govern updates to modality standards based on performance results, benchmark data, site feedback and emerging capabilities. Maintain a performance benchmark library and review adoption, performance and value delivery across sites. Recommend corrective actions where standards are not implemented or outcomes are not progressing. Collaborate with other modality excellence leads to ensure consistent Operating System design and reuse of standards. Engage external benchmarks, technology partners and communities of practice to refresh standards and performance targets. What you bring to Takeda: Bachelor’s degree in Engineering, Life Sciences, Operations Management, Supply Chain, Quality, Industrial Engineering or a related discipline. At least 15 years of experience in manufacturing, Quality operations, engineering, maintenance, supply chain, warehouse operations, operational excellence or transformation within pharmaceutical, biotech or another regulated industry. Proven experience defining and deploying standard work, KPI systems, performance standards and operational excellence methods across multiple sites or functions. Demonstrated success using work analysis, performance management and analytics to reduce cost, improve productivity and strengthen process flow. Strong knowledge of regulated Quality processes, including deviations, CAPA, change controls, investigations and documentation workflows. Experience leading structured diagnostics, design sprints, Kaizen events, A3 problem solving and capability-building interventions. Excellent stakeholder-management, influencing and written communication skills. Ability to create practical standards, playbooks, training materials, KPI definitions
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