Tom Rynkiewicz Email and Phone Number
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Tom Rynkiewicz personal email
Compliance professional with over twenty-five years of experience in FDA regulated industries, including over fifteen years focused on computer system implementation and validation. Currently the Vice President of RA/QA for Raland Compliance Partners, responsible for leading the Regulatory and Quality solutions delivery, client relationships, and market positioning. Because of my extensive life science industry experience I am positioned as a trusted partner who can quickly understand client needs and leverage the experience, knowledge, and resources of the Raland team to have an immediate impact on RA/QA projects or strategic initiatives.Member of ISPE, PDA, ASQ and RAPS. ASQ Certified Quality Auditor (CQA) and former Board member for the MW Chapter of PDA
Raland Compliance Partners, Llc
View- Website:
- raland.com
- Employees:
- 44
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Vice President Of Life Sciences Ra/Qa And CommunicationsRaland Compliance Partners, Llc Jan 2018 - Present
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Director, Compliance And ValidationBarry-Wehmiller Design Group Nov 2015 - Jan 2018St Louis, Missouri, UsResponsible for Central Region Regulatory Compliance Practice with accountability for business development, client relationship management, senior project management, and personnel leadership. In addition, as member of the Leadership Team for the Regulatory Compliance Practice responsible for providing guidance and leadership nationally on best practices, as well as development, maintenance, training, and adherence to company quality policies and procedures. -
Vp Ra/QaConsulting Start-Up Apr 2014 - Oct 2015As the VP of RA/QA, I was responsible for leading the company's regulatory and quality solution delivery, client relationships, and market positioning. Business Development objectives are achieved by providing leadership for business planning, outreach to prospective clients, and expanding opportunities within established accounts. I also had primary responsibility for management of the company brand and development/monitoring of annual plans to drive company objectives.
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Branch Manager, West Coast Office And Sr. Director, Business DevelopmentMaetrics, Llc Sep 2010 - Apr 2014Monroeville, Pa, UsResponsible for managing Maetrics' West Coast office and leading our Business Development activities in the Upper Midwest and West Regions. -
Director, Business Systems CsvPerformance Validation Oct 2008 - Sep 2010Indianapolis, In, UsResponsible for developing and leading the Computer Systems Validation (CSV) practice at PV. -
Project Manager (Consultant) To Is PmoAmgen Aug 2008 - Oct 2008Thousand Oaks, Ca, UsProvided regulatory compliance and validation consulting and project management for multiple electronic data management (EDM) upgrades and implementations. -
Principal ConsultantTjr Solutions, Llc Oct 2006 - Oct 2008Principal Consultant providing Project Management, Quality System, Validation, and Compliance services.
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Program / Project Facilitator (Consultant)Amgen Jan 2008 - Apr 2008Thousand Oaks, Ca, UsFacilitated alignment of multiple IS Infrastructure project teams with corporate IS Program success criteria, milestones and manamement expectations.
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Project Coordinator, Validation And Compliance Lead (Consultant)Pfizer Nov 2006 - Jan 2008New York, New York, UsOne of the principal architects of a multi-site MRPII system upgrade. Performed the detailed Conceptual Analysis and after receiving approval developed the Statement of Work, detailed Project Plan and Compliance Strategy. Responsible for setting project milestones and coordinating the completion of all tasks on the Project Plan to meet those milestones. Personally responsible for all Commissioning and Qualification deliverables as well as managing the execution of all protocols. Additionally responsible for development of the project Lessons Learned document to be utilized as a guide for similar iniatives at other Pfizer global manufacturing sites. -
Senior Account Manager And Regional DirectorCssc, Inc. Mar 2006 - Nov 2006Responsible for providing organizational management, leadership and supervision of Midwest and West Coast client projects. Responsible for Midwest and West Coast sales and marketing efforts and managing the recruitment, training, career development and performance of consultants and contractors.
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General Manager And Director Of Business DevelopmentLloyd'S Register Serentec Mar 2004 - Mar 2006London, GbResponsible for providing organizational management, leadership and supervision of all global business development activities. Responsible for development and oversight of all sales and marketing efforts and assuring a consistent image and professionalism is communicated to all current and prospective clients. Responsible for managing the recruitment, training, career development and performance of regional directors. Major accomplishments included the development of a comprehensive Sales and Marketing Plan, a new marketing effort highlighting the value-added client proposition. Successfully led efforts to secure preferred vendor status with major pharma and biotech clients and developed key contact relationships with numerous major pharma, biotech and medical device companies. -
Project ManagerArbour Group Dec 2000 - Mar 2004Responsible for validation of client computer systems including platform hardware and software, ERP, Warehouse Management, and Maintenance Management systems, as well as Custom software applications. Detailed responsibilities for systems development life cycle (SDLC) included development of User Requirement Specifications, Functional Specifications, Validation Master Plans, CGMP and Risk Assessments, and Qualification Protocols (IQ/OQ/PQ) and Reports. Responsible for staffing and management of project staff including validation specialists, technical writers and support personnel, managing protocol execution, deviation resolution / corrective action, and project close-out reports.
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VariousAbbott Laboratories Jun 1986 - Dec 2000Abbott Park, Illinois, UsResponsible for writing and executing Validation Plans, IQ, OQ, and PQ protocols for computerized systems, equipment, facility and utility validation packages in a CGMP regulated pharmaceutical manufacturing facility.Directed work teams of 3-17 members responsible for all aspects of tissue culture and prep operations in compliance with FDA CGMP and CBER regulations. Functional Manager for a multi-site ERP system implementation project, responsible for the development of Standard Operating Procedures, test scenarios, and OQ protocols.Responsible for the Planning and Inventory Control functions for multi-site Fermentation, Biological and Custom Packaging facilities.
Tom Rynkiewicz Skills
Tom Rynkiewicz Education Details
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Western Governors UniversityBusiness Management
Frequently Asked Questions about Tom Rynkiewicz
What company does Tom Rynkiewicz work for?
Tom Rynkiewicz works for Raland Compliance Partners, Llc
What is Tom Rynkiewicz's role at the current company?
Tom Rynkiewicz's current role is Trusted Advisor, Business Strategist, Consensus Builder, and Vice President.
What is Tom Rynkiewicz's email address?
Tom Rynkiewicz's email address is tr****@****ics.com
What schools did Tom Rynkiewicz attend?
Tom Rynkiewicz attended Western Governors University.
What skills is Tom Rynkiewicz known for?
Tom Rynkiewicz has skills like Validation, Fda, Gmp, Quality System, Medical Devices, Computer System Validation, Pharmaceutical Industry, Quality Assurance, Biotechnology, 21 Cfr Part 11, Strategy, Project Management.
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