Bothell, Washington, United States
A results driven executive with a proven track record of leading organizations to achieve significant and measurable financial benefits. A recognized change leader who has: • Managed the strategic planning process for several F500 companies to increase revenue, margin expansion and to simplify operating structures • Led the Quality function, including the deployment Operational Excellence/Lean Six Sigma for multi-billion firms • Delivered 300+ million in financial benefits in healthcare, manufacturing and financial services firms • Implemented technology solutions including ERP systems, web based solutions, Robotics Process Automation and Machine Learning • Held numerous financial leadership roles including managing multi-billion sales targets, ensuring regulatory compliance, improving cash flow from operations by $150M and generating $20M+ in tax savings Certifications: Certified Master Black Belt and Change Management Quality & Regulatory: global regulations and standards for medical device Finance: FP&A, Commercial finance and Underwriting, Tax & Controllership Business Transformation: strategic planning, operational excellence and organizational restructuring
Establish and execute the quality strategy for the firm and accountable for maintaining the overall safety, efficacy and regulatory compliance of Ultrasound's products and its Quality Management System (QMS). Ultrasound is a global multi-billion dollar medical device company. – Led the transformations to integrate/consolidate multiple Legal Manufacturers/QMSs and to simplify and optimize processes to increase quality and productivity – Proactively ensure the business operates in a state of full compliance and inspection readiness – Responsible for meeting/exceeding Quality Objectives/KPIs (e.g. CAPA timeliness, average findings/audit etc.) – Management Representative and Official Correspondent for the FDA and other global regulatory agencies, including Person Responsible for Regulatory Compliance – In partnership with key stakeholders, develop and maintain a Culture of Quality, first-time-right mindset – Attract, develop and retain a high performing team while effectively managing the department's budget
Develop the strategic plan for the Global Quality and Regulatory Affairs (RA) functions at Medtronic, a $30B Medical Devices company that serves 70M patients with 98,000 employees. Responsibilities include: – Developed and executed the strategic plan for the global Q&R function to achieve the financial commitments and optimize processes, while improving the quality of the outcomes and reducing the time to market – Led the application of Robotics Process Automation and Artificial Intelligence capabilities to optimize processes in complaint handling, customer service and supplier quality – Led the organizational restructuring of the RA function – Built an enterprise Labeling Center of Excellence (COE) and lead the Labeling European Union Medical Device Regulation (EU MDR) workstream to enable the firm to effectively comply with the new regulatory requirements to maintain market access ($6B in revenue) while developing scalable processes and technology solutions to bend the cost curve.
Led Operational Excellence organization (35+ Master Black Belts and Black Belts) to deploy Lean Six Sigma (LSS) across the $50B Pharmaceutical Benefit Management (PBM) business, while developing roadmaps to increase revenue & drive $35M+ in annual savings. Sample initiatives include: – Optimize and streamline core business processes to ensure: - Patients receive the right medication by their need date to ensure they can adhere to their treatments and lead healthier lives - Core business processes can deliver to our Clients and Members expectations right the first time while increasing productivity and year over year savings of $35M+ – Create a Culture of quality by hiring a core staff of Lean Six Sigma Master Black Belts/Black Belts
Engage the senior leadership team across all OptumHealth business segments to develop the strategic roadmap for the Quality & Continuous Improvement (QCI) teams that support individual business segments – Led the redesign of the User Experience of self-serve tools for the Vision and Dental businesses. Optimized the user interface for both members and providers and developed new tools that increased the self serve rate by 25% – Supported the effort to successfully retain the single largest contract signed by OptumHealth within the public sector. Assessed the integrity of the end-to-end system and identified key process gaps – Increased the productivity of the 200-person Call Centers by eliminating rework and waste
Led the global deployment of Lean Six Sigma (LSS) to create a culture of continuous improvement in order to optimize and manage the performance of the core business processes for Finance, Human Resources, Shared Services, Information Technology, Legal, Compliance & Real Estate) – Trained executive leaders as champions and stakeholders (70+ senior leaders) – Mentored and developed 17 Black Belts and 30+ Green Belts in Six Sigma methodology and tools – Developed Lean Six Sigma training material (DMAIC, DMADV and Lean)