Roger Davy Email & Phone Number

Carlsbad, CA, US

Durham, NC, US

CREO works with the world’s most promising life sciences and health care companies to help advance innovation in human health. Our management consulting and advisory services solve growth challenges with confidence to realize your ultimate goals.

Santa Barbara, CA, US

USDM Life Sciences is a global technology consulting firm focused on digital transformation, regulated and unregulated data management and compliance solutions for the world’s leading and emerging biotechnology, pharmaceutical and medical device companies.As the VP of Consulting, I am responsible for the performance of the consulting business and I build.

Santa Barbara, CA, US

• IT Strategy and Roadmaps, Cybersecurity Maturity Programs Compliance Programs and IT Investment decision making for multiple early stage life-sciences orgs, pre clinical, clinical and commercial phases.
• Pre-commercial biopharmaceutical Company, Boston MA - Reporting to executive team, led strategic Commercial Readiness program across 3 sites and the Clinical, Regulatory Affairs, PV and IT functions. Included Policies.
• Commercial medical device company, San Clemente CA - Reporting to the Digital Transformation Leader and Head of Business Systems, led the Computer Systems Validation effort for Oracle Cloud ERP.
• US Food and Drug Administration, Silver Spring MD - Led the team contracted to establish and manage FDA's DSCSA pilot project program mandated under 2013's federal Drug Supply Chain Security Act.
• Pre-commercial biopharmaceutical company, Boston MA - Sponsored by the IT department, led an engagement to help prepare this public company for commercial transformation. Included Quality Assurance, IT systems strategy.
• Major global biopharmaceutical public company, Boston MA - Led a GxP and CSV compliance effort that Included an evaluation and prioritized recommendations, together with training and organizational change efforts.

Lead IT on a retained basis for this innovative clinical phase pharma

Lead IT function. Strategy, Security, Operations

Cambridge, Cambridgeshire, GB

• Inhaled Products Division leadership for Digital Transformation projects supporting commercial, clinical and R&D manufacturing, drug development and multiple successful regulatory submissions.
• Regulatory compliance, including 21 CFR Part 11, GAMP and GMP; SDLC and Risk Based methodologies; Data Integrity; Validation
• LIMS and ELN – Strategy and Execution, Enhancements, Integrations, Regulatory Submissions, Compliance. ELN solution deployed to multiple business areas and integrating with AstraZeneca Global LabWare LIMS resulting in.
• Calibration and Maintenance Management System – Enabled migration from paper to electronic records for GMP and R&D operations across two sites, improving operations and quality
• PDM – Project leadership for Product Data Management system architecture, configuration, documentation and validation supporting GMP, R&D and Facilities operations across two sites
• Manufacturing Data Historian – Project leadership for selection, configuration, documentation, validation and implementation in a phased approach to electronic batch records

Basking Ridge, New Jersey, US

• Design, delivery and validation project: Customized SaaS ELN solution in support of CMC for successful Bevespi US NDA
• Enhancements project: Customized SaaS LIMS solution for use by Contract Research Organizations (CROs). Improvements include study workflow, data review and approval workflow, and data export customization and data.
• Asset Management / CMMS System: Lead end to end company-wide Computerized Maintenance Management System project from concept to selection, analysis, design, validation and documentation through implementation

Irvine, CA, US

• Lead specialist for IT Systems services at this Life Sciences consulting firm
• Partnered with clients for systems strategy, selection, design, documentation, validation, implementation and maintenance
• Consulted to Pharmaceutical, Contract Research and Medical Device organizations in R&D and GxP contexts and analytical science and manufacturing business areas
• Provided leadership and guidance for process optimization, automation, operating procedures, documentation and compliance (FDA and GAMP)

Los Angeles, CA, US

Graduated top of MBA cohort with a GPA of 3.94

Burlington, MA, US

• Hired to perform an end to end evaluation of a B2B ecommerce platform, including conformance to requirements and production readiness
• Established standards for ecommerce partner development; identified strongest potential partners and led engagements
• Generated complete operating models; made technical and commercial recommendations to COO and CFO

Santa Clara, CA, US

Led Strategic Systems and Process initiatives across functions to support business strategy and improve performance of this global $1.8B product group

Santa Clara, CA, US

• Achieved a 35% reduction in project cost by developing and executing strategic process improvements including systems redesign and implementation
• Accomplished a 40% reduction in warranty cost by improving business processes, aligning systems and developing measurements (Key Performance Indicators) to drive ongoing improvements

Santa Clara, CA, US

• Directed the global Installation and Warranty (I&W) program for complex semiconductor production system annual sales over $1B
• Employed extensive data analysis to reduce division I&W cost from $54M to $47M over seven quarters, saving 0.7 margin points
• Designed and implemented a direct exchange / reverse logistics program to recover over $3M annually from Original Equipment Manufacturer (OEM) sources.
• Shortened average system installation time by 15% from over 35 days to under 30, reducing cost improving the balance sheet

Santa Clara, CA, US

• Enabled our etch systems to achieve ‘Preferred Tool of Record’ status at TSMC in Taiwan and Samsung Electronics in Korea by managing hardware, software, productivity and customer expectations
• Completed new product introductions for $3M production tools at UMC and ensured compliance with customer specifications; obtained customer acceptance to allow revenue recognition
• Field qualified OEM and second source assemblies in the most critical production environments

North Ryde, AU

• As the senior customer engineer for the state of Western Australia, specified, designed and sold customized gas solutions; exceeded financial and customer satisfaction targets
• Supervised the construction, commissioning and handover of on-site gas plants; consulted to manufacturing customers in mining and metallurgy, oil and gas, utilities and pharma

North Ryde, AU

• Designed gas control and distribution systems for innovative products.
• Achieved standardization by technology transfer to regions and overseas affiliates.
• Developed models of process behavior as specification and sales tools.

Master Of Business Administration (Mba)

Bachelors, Chemical Engineering