Associate Director, Operational Excellence

Position Summary

The Associate Director, Operational Excellence leads the development and implementation of continuous improvement (CI) and operational excellence (OE) strategies, programs, and practices for the Bothell Cell Therapy manufacturing site. Reporting to the Director, Strategy & Business Operations, this role manages the operational excellence team and provides expert guidance to site leadership on deploying continuous improvement principles and tools in a GMP-regulated, patient focused environment. This role drives a continuous improvement culture through implementation of OE practices and behaviors in a harmonized manner across site and network functions that aligns with the broader BMS operational excellence framework. In partnership with leaders across the site, this role leverages the OE skillset to implement improvements in right-first-time performance, turnaround time, capacity, and cost, ensuring these efforts tie directly to strategic site objectives and deliver sustained value for the site.

Key Responsibilities

• In partnership with the Director, Strategy & Business Operations and site leadership, develop and execute the site operational excellence strategy and roadmap aligned with site annual and long term goals
• Embed OE capability and a performance management culture at the site by deploying and sustaining the site operating system (visual management, lean leadership, etc.) in alignment with the broader BMS OE framework
• Align site KPIs and tier management dashboards with network and site strategy and objectives
• Manage the OE team’s book of work including contribution to strategic initiatives, intake of ad hoc requests, prioritization across competing efforts, benefits tracking, and reporting to leadership
• Lead and coach the OE team, setting goals, allocating resources, driving delivery, and developing skills
• Use data analysis to enable site identification, selection and implementation of OE initiatives
• Partner with site leaders to deliver measurable improvements in key site metrics tied to strategic objectives
• Advise senior leaders as the site's CI expert, guiding them in understanding and deploying CI principles
• Facilitate high-impact, complex improvement workshops, kaizens, and Lean Six Sigma/DMAIC projects
• Strengthen continuous improvement competencies across the organization through training, workshops, facilitation, role modeling, coaching, and constructive feedback
• Represent and advocate for the site in network and global operational excellence forums

Qualifications & Experience

• Bachelor's degree in Engineering, Life Sciences, Operations, Business, or equivalent discipline
• 10+ years of experience in operations, manufacturing, continuous improvement, or related functions
• 5+ years hands on experience applying operational excellence principles
• 3+ years of experience leading people or teams through direct or project/matrix leadership
• Demonstrated proficiency in, and passion for, OE methodology, tools and manufacturing process improvement (e.g. lean leadership, visual management, kaizen, DMAIC, structured problem solving)
• Demonstrated success leading continuous improvement initiatives to achieve strategic results
• Strong data driven analysis and decision making skills
• Working knowledge of GMP or similar quality-regulated environments
• Demonstrated application of project management and change management principles in achieving results
• Strong relationship builder with the ability to drive alignment across a range of levels and functions
• Exceptional skills in coaching, facilitation, and analytical problem solving
• Advanced written/verbal communication, presentation and interpersonal skills
• Proficient in MS Excel, PowerPoint, Teams, SharePoint, and Outlook

Preferred Experience

• Experience in a regulated high tech/manufacturing industry
• Understanding of cGMP regulations and FDA guidance applicable to biopharma or medical devices
• Experience in cell therapy, gene therapy, biologics, or other personalized or small-batch manufacturing
• Strong business acumen with ability to strategically connect continuous improvement to business value
• Experience with data mining and data analytics for KPI reporting
• Lean Six Sigma Black Belt, Shingo or equivalent certifications
• Experience building or sustaining a site operating system or daily management system
• Familiarity with deviation, CAPA, and change control processes
• Training or certification in change management or project management