Shane Lutz Email and Phone Number

• Pioneered programmatic updates that streamlined assessment and project planning for hundreds of organizations globally, impacting 191 management systems across 6 continents. These updates simplified processes, making fit-for-purpose changes to enhance the experiences of billions of individuals.• Leveraged advanced technological skills including SQL, Azure, SharePoint, PowerApps, Power Automate, Power BI, QlikSense, QlikView, and Tableau. Successfully integrated data from diverse applications (ARIS, TrackWise, SAP, Salesforce, Planisware, Clarity, and other systems) to optimize database development, application maintenance, and reporting functionality.• Established a direct link between advanced data utilization efforts and tangible outcomes. Visualized real-time data for transparency, communication, and informed decision-making. These inputs led to improved planning accuracy, streamlined decision-making, accelerated business transformation, and proactive issue detection.• Orchestrated cross-functional teams by employing dynamic leadership skills to lead initiatives from planning through execution. Drove impactful process improvements through lean methodologies, fostering efficiency and collaboration across verticals.

• Led scaled development, integration, and continuous improvement of quality management systems for three start-ups, two acquisitions, and two established businesses.• Functioned as a quality management system architect for programmatic consolidation of legal manufacturers across global diagnostic imaging and health informatics organizations, leading to worldwide adoption of best practices by Philips' business transformation.• Provided quality operations leadership in lean start-ups with an emphasis on health software and related professional services utilizing ScaledAgileFramework (SAFe5.0), DevOps and Customer Success Management.• Collaborated seamlessly with functional business groups to enhance system interfaces, facilitating efficient coordination and streamlined communication.• Transformed critical processes and culture utilizing Lean Six Sigma and Baldrige Healthcare Framework to ensure compliance, drive efficiency, and enhance effectiveness.• Successfully executed strategic quality management system improvements, aligning with company objectives and regulatory requirements.• Conducted inspections of businesses to ensure compliance with applicable medical device and healthcare standards and regulations.• Drove process improvement through CAPA and SOP updates, fostering continuous improvement in operations.

• Redefined Quality Management Systems processes including Change Control, Design Control, CAPA/Investigation, and Regulatory Reporting for seven sites in North America.• Led the corporate initiative to redesign, train, and deploy Change Control and Design Control synergistically to drive consistent understanding between product innovation, operations, and stakeholders resulting in successful adoption at all sites in North America, enabling compliance and innovation through key changes to QSRs, ISO13485, and preempting MDSAP and MDD to MDR in the regulatory landscape.• Utilized Lean and Six Sigma approaches for compliance and effectiveness with an emphasis on GEMBA to coach and advise operations leadership in the identification of areas for continuous improvement.

• Provided quality operations oversight during Consent Decree Remediation, ensuring compliance, the ability to supply critical drugs, and expand operations capabilities.• Quality reviewer and approver for manufacturing equipment qualification and process validation leading to Pre-Approval Inspection of two production lines during remediation.• CAPA and Change Control facilitator, coach, and owner through a sitewide initiative to reestablish best practices and create a culture of continuous improvement.• Leader of technology transfer quality assurance efforts in support of two new production lines and as a representative to R&D from bench through scale.

• Led a 24/7 team of 32 operations personnel engaged in the manufacture of recombinant vaccines and products for sterile injection.• Directed cross-functional teams, driving process improvements, CAPA, and resolution escalation with an emphasis on operational excellence.• Collaborated with technology and compliance groups to drive continuous improvement initiatives in operations.• Demonstrated leadership in high-stress and adverse conditions with a focus on ownership, ensuring inclusion of employees at all levels.• Contributed as a member of the transition team responsible for migrating enterprise resource planning to SAP and site conversion to electronic batch records using Werum PAS-X MES.Developed business processes for all Biological Vaccine Manufacturing as part of the SAP and PAS-X conversion.

• Coordinated educational laboratory activities and maintained laboratory environments.• Provided technical support for anatomy & physiology and microbiology laboratory components.

• Led instruction of classroom and field training for college-age American and international students.• Coordinated fundraising and volunteer outreach to local communities to provide aid for medical clinics, elementary schools, microlending, and infrastructure improvements.• Specialized in the areas of physical anthropology, archaeology, demographics, and site survey.

• Achieved inside sales goals, managed customer support requests, and conducted client-based training with a strong focus on delivering excellent customer service.

• Led site survey of active excavations of the Pambamarca Research Project with oversight of the survey team.• Conducted field testing and topographic survey of an extended network of sites surrounding Pambamarca, a high-altitude site located on a remote peak in the Ecuadorian Andes.• Compiled GIS data for active excavations and exploration to identify future research in the region.• Assisted in instruction, excavation, laboratory analysis, and supervision of students and participants.

• Validated laboratory techniques and trained staff for a pilot study to assess primate development and health.• Conducted research and managed a serological study comparing wild and zoo primate populations to evaluate overall health and breeding population fitness.

• Cited staff contributor: Sturtevant WC Ubelaker DH Smithsonian Institution. Handbook of North American Indians. Volume 3. Environment Origins and Population. Washington D.C: Smithsonian Institution; 2006.• Conducted research, procurement, and authentication of illustration materials for academic publication.• Coordinated international academic collaborations to achieve project goals.• Advised publication editorial staff on multifaceted scientific content, including biology, climate studies, geology, anthropology, and archaeology.

• Validated serological and microbiological assays to support the Quality Control release of products and intermediate products.• Developed ELISA assays to enhance quality control testing for avian influenza contamination of egg-derived vaccine intermediate products.

• Delivered classroom and laboratory instruction to undergraduate and graduate students in biological sciences.• Conducted research in behavioral neuroscience, focusing on the hormonal connection between male sexual behavior and the maintenance of the central and peripheral nervous systems.