2010 -2014 Branch Manager, West Coast Office and Sr. Director, Business Development @
2008 -2010 Director, Business Systems CSV @
2008 -2008 Project Manager (Consultant) to IS PMO @
2006 -2008 Principal Consultant @ TJR Solutions, LLC
2008 -2008 Program and Project Facilitator (Consultant) @
2006 -2008 Project Coordinator, Validation and Compliance Lead (Consultant) @
2006 -2006 Senior Account Manager and Regional Director @ CSSC, Inc.
2004 -2006 General Manager and Director of Business Development @
2000 -2004 Project Manager @ Arbour Group
1986 -2000 Various @
Tom Rynkiewicz Education
Western Governors University
Bachelor of Science (Business Management)
2016
Tom Rynkiewicz Skills
Validation
FDA
GMP
Quality System
Medical Devices
Computer System Validation
Pharmaceutical Industry
21 CFR Part 11
Quality Assurance
Biotechnology
Strategy
SOP
Project Management
Leadership
CAPA
Change Management
Software Documentation
SDLC
ERP
Strategic Planning
ISO 13485
Compliance
Lifesciences
Quality Auditing
V&V
Risk Management
New Business Development
Requirements Analysis
Life Sciences
Business Development
Gap Analysis
GAMP
Biopharmaceuticals
Solution Development
Enterprise Software
Full SDLC
Remediation
cGMP
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
Software Development Life Cycle (SDLC)
Standard Operating Procedure (SOP)
Corrective and Preventive Action (CAPA)
Regulatory Requirements
Tom Rynkiewicz Summary
Tom Rynkiewicz, based in Chicago, IL, US, is currently a Director of Validation at Technical Safety Services. Tom Rynkiewicz brings experience from previous roles at Raland Compliance Partners, LLC, Barry-Wehmiller Design Group, Consulting Start-Up and Maetrics, LLC. Tom Rynkiewicz holds a Bachelor of Science in Business Management @ Western Governors University. With a robust skill set that includes Validation, FDA, GMP, Quality System, Medical Devices and more. Tom Rynkiewicz has 4 emails and 6 mobile phone numbers on RocketReach.
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