Dianne Pistone
Senior Manager, Systems Integration at Roche
- Role
- Senior Manager, Systems Integration at 罗氏公司
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Dianne Pistone
Strategic Systems Integration/ Systems Engineering Leader with a demonstrated history of building innovative World Class Teams and achieving successful quality products in challenging fast paced environments while working in the biotechnology/ medical device industry. Consistently uses expert knowledge to anticipate a wide range of future needs and opportunities and facilitates development of complex solutions. Significant FDA/ Global regulation expertise for the highly regulated healthcare industry. Skilled in Medical Device System, Reagent, and Sensor development and product on-market support, Requirements elucidation/ management, Design Verification and Validation (DV & V), Regulatory Affairs, Quality Systems, Compliance, ISO/ FDA, CE Mark, CAPA resolution, Change Control, Process Control, and Manufacturing Operations for the Oncology/ Clinical Diagnostics fields.
Experience
Senior Manager, Systems Integration
Jan 2012 — Present
Lead a variety of projects (digital pathology, workflow, platform systems, etc.) through development/ systems engineering processes including requirements elucidation and management, system architecture, risk assessments, design characterization, verification, and validation while assuring compliance (FDA/ Global) within a regulated medical device industryShifted company\'s strategy and approach to a test and requirements driven/ risk based product development processDirected strategy and development of company\'s first configuration management processDeveloped strategy and guidance to decrease staining required for adding new features to existing products reducing time to market by 45% and associated costs and testing by >66%Created the current company-wide strategy, methodology, and process for Design Verification and Validation (DV & V) of all new and on-market products (Digital Pathology, Workflow, Staining platforms, etc.)Direct all DV & V and system characterization activities for all platformsDevelop custom databases (web based & other) and data mining tools for all characterization and DV & V activities
Education
Boston University
BA, Physics, Chemistry
Skills
- Change Control
- Six Sigma
- Product Launch
- Chemistry
- Clinical Trials
- Gmp
- Quality System
- V&V
- Integration
- Process Simulation
- Hardware Diagnostics
- Computer System Validation
- Oncology
- Hplc
- Biotechnology
- Research and Development (R&D)
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Clinical Development
- Management
- Glp
- Regulatory Affairs
- Lifesciences
- Process Improvement
- Quality Assurance
- R&D
- Medical Devices
- Capa
- U.s. Food and Drug Administration (Fda)
- Biomedical Engineering
- Manufacturing
- Product Development
- Technology Transfer
- Biochemistry
- U.s. Title 21 Cfr Part 11 Regulation
- Design Control
- 21 Cfr Part 11
- Iso 13485
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