Associate Director, Operational Excellence

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.