Director, Modality Excellence – Indirect Processes, Quality, Engineering & Maintenance, and Warehouse

USA - 3390 Baxalta U.S., Inc.; Lexington (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda in Lexington, MA seeks a Director, Modality Excellence to codify and deploy global standards for indirect and enabling processes across manufacturing. You will drive a repeatable Operating System, standard work, KPI hierarchies and cost-focused improvements in a regulated environment.

The role leads diagnostics, design sprints, and deployment activities with site leadership and cross-functional teams, ensuring adoption and sustained value delivery.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• MBA or advanced degree is desirable.
• Minimum 15 years in manufacturing, Quality, engineering, maintenance or transformation in regulated industries.

Responsibilities

• Define operating system elements and KPI architecture across modalities.
• Translate benchmarks into practical, auditable standard work.
• Lead diagnostics, design sprints, and Kaizen events to deploy standards.
• Coach leaders in KPI management and standard work adoption.

Skills

Stakeholder management

Strategic thinking

Leadership

Communication

Transformation experience

Education

Bachelor’s degree in Engineering

MBA or advanced degree desirable

Tools

AVIX

LPMS

A3 problem solving

Job description

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. This position is anticipated for a duration of 2 years.

How you will contribute:

• 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 and performance‑management routines.
• Experience with AVIX or similar work‑measurement and work‑content analysis tools is preferred.
• Experience with LPMS or an equivalent Lean Performance Management System is preferred.
• Experience identifying and deploying AI or advanced analytics use cases in operations, Quality, maintenance or warehouse environments is preferred.
• Lean Six Sigma Black Belt, Master Black Belt or equivalent Operational Excellence certification is preferred.
• An advanced degree such as an MBA or Master’s in Engineering, Operations, Quality or Supply Chain is desirable.
• Global multi‑site experience in pharmaceutical, biotech or another highly regulated industry is desirable.
• Ability to act as a trusted global authority and influence without direct authority.
• Ability to communicate effectively from enterprise strategy to frontline standard work.
• Ability to balance global standardization with justified site‑specific adaptation based on risk, maturity, technology and process complexity.
• Ability to make evidence‑based recommendations on AVIX, LPMS, AI, digital solutions, automation and process redesign.
• Sound Director‑level judgment when navigating GxP, compliance, safety, quality, service, capacity and cost trade‑offs.

Commitment to Takeda’s values and priorities:

Integrity, Honesty, Fairness, Perseverance, Patient Trust, Reputation and Business.

Willingness and ability to travel according to deployment needs and site‑support priorities.

Ability to engage frequently with global, regional, site and senior leadership stakeholders.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Lexington, MA U.S.

Base Salary Range: $177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type Employee Worker Sub-Type Fixed Term (Fixed Term) Time Type Full time Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.