Associate Director, Operational Excellence # 4890

The Associate Director, Operational Excellence is central to driving continuous improvement, operational rigor, and data-informed decision-making across laboratory and operational workflows. The ideal candidate combines deep analytical capability with proven experience in Lean methodologies and cross-functional leadership. They will play a critical role in transforming operational data into actionable insights, enabling scalable, high-quality execution in a regulated environment.

This role works on-site full-time at our office located in Durham, NC

Responsibilities:

• Operational Data & Insights
  • Design, develop, and maintain operational dashboards and data visualizations to provide real-time visibility into performance
  • Generate and distribute KPI reports, ensuring clarity, accuracy, and alignment with organizational goals
  • Partner with stakeholders to define meaningful metrics and continuously improve reporting frameworks
  • Data Exploration & Process Monitoring
    • Conduct deep data analysis to identify trends, anomalies, and leading indicators related to Statistical Process Control (SPC) and Quality Control (QC)
    • Establish and refine control limits, early warning systems, and predictive indicators to proactively manage operational risk
    • Translate complex data findings into clear, actionable recommendations
    • Continuous Improvement Leadership
      • Lead and scale Lean initiatives, including 5S, Six Sigma, and Kaizen programs, across operational teams
      • Drive a culture of continuous improvement through structured problem-solving and iterative refinement of processes
      • Measure and track the impact of improvement initiatives, ensuring sustained gains
      • Issue Management & Prioritization
        • Develop and maintain a centralized system for capturing operational issues, risks, and improvement opportunities
        • Synthesize inputs across teams into a structured backlog of initiatives
        • Partner with cross-functional stakeholders (e.g., Engineering, Software, Lab) to prioritize and align on improvement efforts
        • Cross-Functional Collaboration
          • Act as a key liaison between Operations and non-Operations teams to drive execution of improvement initiatives
          • Ensure alignment on priorities, timelines, and expected outcomes
          • Influence without authority to remove barriers and accelerate progress

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Operations, Data Science, or related field (advanced degree preferred)
• 12+ years of experience in operational excellence, process improvement, or analytics, ideally in biotech, diagnostics, or regulated environments
• Demonstrated expertise in Lean, Six Sigma (Green Belt or Black Belt preferred), and Kaizen methodologies
• Strong experience with data visualization tools (e.g., Tableau, Power BI, Looker) and data analysis (SQL, Python, R, or similar)
• Proven ability to work with SPC/QC frameworks and operational performance metrics
• Experience leading cross-functional initiatives and influencing senior stakeholders
• Excellent problem-solving, communication, and organizational skills
• Experience in NGS, clinical laboratory operations, or diagnostics workflows
• Familiarity with regulated environments (CLIA, CAP, FDA) preferred

Physical Demands and Work Environment

• Work performed across office, production, and executive settings.
• Exposure to manufacturing environments, including noise, chemicals, and production equipment.
• Extended or flexible hours may be required to meet organizational goals.
• Use of personal protective equipment (PPE), including safety glasses, gloves, and hearing protection, required in designated areas.