Quality Assurance Manager and Test Manager @ Life Sciences Company (January 2017 - January 2018)
Senior Program Manager and Senior Project Manager @ (January 2017 - January 2017)
Quality Assurance Manager and Validation Manager @ (January 2016 - January 2017)
Senior Program Manager and Senior Project Manager @ (January 2015 - January 2016)
Senior Program Manager and Senior Project Manager @ (January 2014 - January 2015)
Project Manager and Quality Assurance Manager @ (January 2013 - January 2014)
Quality Assurance Manager and Validation Manager @ (January 2011 - January 2013)
Program Manager and Project Manager @ (January 2011 - January 2011)
Quality Assurance Manager and Validation Manager @ (January 2008 - January 2011)
Program Manager and Project Manager @ (January 2008 - January 2008)
Quality Assurance Manager and Validation Manager @ (January 2007 - January 2007)
Program Manager and Project Manager @ (January 2006 - January 2007)
Project Manager and Quality Assurance Manager @ (January 2005 - January 2006)
Quality Assurance Manager and Validation Manager @ (January 2002 - January 2004)
Program and Project Manager, QA and Validation Manager @ Independent It Consultant Considering Full Time Roles (January 1990 - Present)
Lou Naples Education
New Hampshire College, summa cum laude
Lou Naples Skills
Project Management
Program Management
Project Management Office (PMO)
Test Management Office (TMO)
Organizational Change Management (OCM)
Software Development Life Cycle (SDLC)
SDLC
Risk Management
Compliance
Regulatory Compliance
Business Continuity
Disaster Recovery
Quality Assurance
Vendor Management
Requirements Managements/Gathering
Requirements Analysis
Business Process Analysis/Mapping
CSV
Testing
Business Assessments
Impact Assessments
Regulatory Assessments
GxP Assessments
Risk Assessments
Technical Assessments
Validation Assessments
Vendor Assessments
Compliance Audits
Operational Audits
Quality Audits
Technical Audits
IT Audit
Vendor Audits
Change Management Plans
Coaching Plans
Communication Plans
Oversight Plans
Resistance Plans
Training Plans
Transformation Plans
Transition Plans
21 CFR Part 11, 50, 54, 58, 210, 211, 312, 820
CAPA
ARGUS
ARISg
SAP
Trackwise
Veeva
Documentum
Computer System Validation (CSV)
Lou Naples Summary
Lou Naples, based in New York, NY, US, is currently a Program Manager, Project Manager, Quality Assurance Manager, Validation Manager at Independent It Consultant/Contractor. Lou Naples brings experience from previous roles at Life Sciences Company, Pfizer, Ibm and Forum Pharmaceuticals. Lou Naples holds a New Hampshire College, summa cum laude. With a robust skill set that includes Project Management, Program Management, Project Management Office (PMO), Test Management Office (TMO), Organizational Change Management (OCM) and more. Lou Naples has 6 emails and 1 mobile phone numbers on RocketReach.
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