Hired to define and establish a new IT Quality department within IT. Based on interviews with over 25 internal IT leaders, define and implement the charter for a new IT Quality organization. Lead team to proactively create procedures, templates, job aids, checklists, and training to build an IT organization setup for compliance success. Establish and manage detective controls to ensure compliance and quality. Train and manage corrective actions to defeat previous errors and prevent recurrence. Innovate for changing IT and business landscapes to meet regulatory and business needs. Develop, evolve, and present insightful and meaningful metrics to identify business needs and drive financial and strategic decisions. Collaboration with Commercial, Infrastructure, R&D, Core Business Functions, Global Process Quality, Global Product Quality. Lean, Computer Software Assurance (CSA), Artificial intelligence and Machine Learning (AI/ML), CAPA, 5-Why, Root Cause Analysis (RCA), Corrective Action, Training, Compliance, Chatbot, • Manage small team (8 - 15 people) in U.S. and India• Create and lead Quality and Compliance function for IT organization of 900+ people• Establish a new governance and expand the IT Quality audit team by 29% in 12 months• Redefined IT training strategy and improved IT training compliance by 30% in 10 months• Completed 13 CAPAs to successful, effective closure•

Associate director for quality systems, including internal quality audits, CAPA review board, and quality system and production software validation. Re-establish quality audit program for company rebounding from multiple FDA warning letters in recent years at the company’s global headquarters. Ensure auditor training and site compliance to all applicable FDA quality system regulations, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). Complete activities for remediation of validation of software and spreadsheets used in quality system and production applications. Establish and nurture healthy working connections between Quality and Manufacturing, Regulatory, Clinical, IT, Marketing, and R&D. • Manage small team (8 - 12 people) in U.S. and India• Quality leadership at the global headquarters for $8 billion worldwide leader in orthopedic implants• Grow the internal Quality audit team by 67% in 15 months and increase audit activity by 25%• Streamline quality audit and software validation through introduction of validated workflow tools and electronic signatures• Direct interface with 4 notified bodies and competent authorities, including FDA, BSi, Ukraine, and Kazakhstan, in quality system audits• Lead relationship with ISO Notified Body to coordinate site quality management certificates and arrange quality system audits• Manage $1.3 million annual department budget, including salary, hourly, and contract resources• Owned and completed 5 CAPAs created from external audit nonconformances to successful, effective closure

Senior manager for R&D compliance engineers, blood glucose meter safety and certification engineers, and IT validation experts. Overall software process owner for medical device product software and IT / operations software. Extracted data from Bayer IT systems and established cost-effective replacement systems for Ascensia. Established right-sized planning, definition, implementation, validation, deployment, and change management processes to maximize cost effectiveness. Aligned new product development processes with sister company to eliminate redundancy and reduce project cost.• Managed small team (6 - 10 people) in U.S., Europe, and India• Led the compliant transition of 500+ Bayer Diabetes Care business applications to 70 replacement solutions for Ascensia Diabetes Care in 21 months from January 2016 to October 2017• Reduced business IT license and operational costs by over $20 million per year• Delivered 33 blood glucose monitoring and data management systems• Combined medical device R&D design reviews with Japanese sister company to reduce design review meetings and process overhead by 50% from August 2017 to April 2018• Completed the decommissioning and sale of >$500,000 equipment and assets for the closure of a 130,000 sq ft manufacturing facility• FDA, ISO, and customer audit defense for design control and validation

Managed R&D compliance engineers, blood glucose meter safety and certification engineers, and IT validation experts. Business owner for 40+ quality system engineering procedures.• Managed medium sized team (15 - 25 people) in U.S. and India• Established IT software compliance department and processes• Delivered 18 blood glucose monitoring systems, 4 contrast media injection systems, 6 tele-health solutions, and over 50 data management software releases across PC, Mac, and mobile platforms• Spearheaded engineering process improvement project in 2009 – 2010 to reduce medical device R&D in-process defects by 15% and overall R&D cycle-time by 15%• Implemented FDA Unique Device Identification (UDI) for Class 1, 2, and 3 devices• Introduced and implemented R&D software engineering and validation processes into 2 acquisitions• Implementation and validation of TrackWise for CAPA and audits• Introduced processes for IEC 62304 compliance and Software As a Medical Device (SAMD) validation• Performed root cause analysis and led resolution for over 15 CAPAs related to R&D engineering and IT validation• QA representative on 9 medical device R&D software development teams• Led implementation of 3 procedures for medical device R&D software risk management and spreadsheet validation• Executed 8-10 software compliance audits annually• FDA and ISO audit defense for design control and validation