Associate Director, Operational Excellence

Associate Director, Operational Excellence – Cell Therapy Manufacturing

Location: Bothell, Washington, USA

Salary: $184,270–$223,294 per year

Role Overview

Lead operational excellence and continuous improvement strategy at a cell therapy manufacturing site. This role manages the Operational Excellence team, advises site leadership and drives measurable improvements in manufacturing performance, quality, capacity, turnaround time and cost within a GMP-regulated environment.

Key Responsibilities

• Develop and implement the site's operational excellence strategy and continuous improvement roadmap.
• Embed Lean leadership, visual management and performance management practices across site operations.
• Align KPIs, dashboards and tier management processes with site and network objectives.
• Lead and develop the Operational Excellence team, managing priorities, resources, delivery and benefits tracking.
• Use data analysis to identify improvement opportunities and measure business impact.
• Partner with site leadership to improve right-first-time performance, manufacturing capacity, turnaround time and cost.
• Facilitate complex improvement workshops, Kaizen events and Lean Six Sigma/DMAIC projects.
• Coach teams and leaders on continuous improvement methods, structured problem-solving and change management.
• Represent the site in global and network-wide operational excellence initiatives.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Operations, Business or a related discipline.
• 10+ years of experience in operations, manufacturing, continuous improvement or a related field.
• 5+ years of hands-on experience applying operational excellence principles and tools.
• 3+ years of people leadership, project leadership or matrix team management experience.
• Demonstrated success delivering measurable continuous improvement initiatives.
• Knowledge of GMP or other quality-regulated manufacturing environments.
• Experience with Lean leadership, visual management, Kaizen, DMAIC and structured problem-solving.
• Strong analytical, project management, change management, facilitation and stakeholder management skills.
• Proficiency in Microsoft Excel, PowerPoint, Teams, SharePoint and Outlook.

Preferred Qualifications

• Experience in biopharmaceuticals, cell therapy, gene therapy, biologics, medical devices or other regulated manufacturing environments.
• Knowledge of cGMP regulations and applicable FDA guidance.
• Lean Six Sigma Black Belt, Shingo or equivalent certification.
• Experience with KPI reporting, data mining and analytics.
• Experience establishing or sustaining a site operating system or daily management system.
• Familiarity with deviations, CAPA and change control processes.
• Project management or change management certification.