July 22 2024 was my last official day at Takeda. Driving change in Global Regulatory Affairs for the past 6 1/2 years has been a fulfilling experience. After a 40+ year career, it’s time for a new chapter in my life.Time for family, friends, fun, philanthropy, nonprofit volunteering, and other possibilities. My entire career I have been learning and evolving my approach to continuous improvement. I am persistent and passionate, not just about processes & technology, but the core of cultural transformation – engagement through respect for people. I see an organization pursuing the journey to excellence just like coaching a sports team – everyone has their strengths and can play their positions to the fullest. Still, they will only succeed if they practice & play together as a team. Integrating proper methods with organizational design creates sustainable improvement. Whether my middle schoolers finish the soccer season undefeated, or a project team makes a great impact on an organization, the satisfaction and pride of the whole team along with parents or company leaders is very rewarding. Results: Employee empowerment, collaboration, satisfaction and retention. Increase quality, operational capacity & agility, process velocity, and cost efficiencies.Specialties: • Creating change through people engagement, critical thinking & growth mindset with positive reinforcement • Global Matrix Team Leadership, Governance & Cross-Functional Engagement • Creating Value through Biopharma Operating System• Teaching, Coaching & Applying Continuous Improvement and Redesign with Lean / 6 Sigma Principles & Methods, Digitization & Automation • Customer Focused New Product Design with Voice of the Customer / Concept Engineering • Employing Human Performance / Error Reduction Techniques • Execution skills – Project Management, Organizational Change Management & Design • Experienced with Learning & Development / Instructional Design / Knowledge Management• FDA Warning Letter Remediation with Global Process Harmonization and Redesign