Description
SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems. QUALIFICATION HIGHLIGHTS Product Manager working with executive teams * Sr. Project Manager and ScrumMaster practicing Agile framework * Expertise in CSV documents including (VP, RS, FRA, IQ, OPQ, TM, VSR) * Regulatory knowledge, 510 (k) and PMA, 21 CFR Part 11, ISO 9001 & 13485 * Assessment of organizational quality, ITAR Compliance training * Process improvements & implementation of QMS features addressing the need for closed loop quality OPERATIONAL NEEDS AND CHALLENGES: My experience in Operations include familiarity with Lab and Manufacturing services and solutions in Life Sciences (Commercial and Clinical quality labs and their processes), engineering ERP for manufacturing and build reliability. These experiences allow me to provide pragmatic solutions to help operations and provide a platform for continuous improvement. REGULATORY KNOWLEDGE: My Regulatory experience around IS solutions provide another dimension to my experience. I understand and practice 21 CFR part 11, Annex 11 daily. It demonstrates operational mindfulness where every decision is scrutinized. ACCOMPLISHMENTS PLM Director and Sr. Project manager responsible for implementation and validation of PTC Windchill as well as several other enterprise quality applications (LIMS, IOT Solutions, DocuSign, Loftware Spectrum, Salesforce, JIRA). * Responsible for full Computer System Validation artifacts, process improvements through the use of SOPs and QMS tools addressing Document Management, Non-Conformance, CAPA, Release and Change Control. * Overseeing development, testing, deployment of software releases and enhancements to the SM LIMS system using Agile methodology. * Product Manager and owner of full product roadmap for several quality applications such as (Document Management, Instrument integration and Inspection Plans, Foreign Object Debris Identification System). * Responsible for day to day project management of several high-profile systems in Scientific Affairs (ex. MedInfo Live Connect communication tool). * Responsible for day to day operation of SampleManager (SM) LIMS where all commercial and clinical testing is performed. This system is responsible for producing the Certificate of Analysis permitting $15 Billion in product LOTs to be released. * Responsible for acquisition and implementation of Chromatography Data Systems hardware more than $500 K.
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