Tom Rynkiewicz Email & Phone Number

St Louis, Missouri, Us

Responsible 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.

As 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.

Monroeville, Pa, Us

Responsible for managing Maetrics' West Coast office and leading our Business Development activities in the Upper Midwest and West Regions.

Indianapolis, In, Us

Responsible for developing and leading the Computer Systems Validation (CSV) practice at PV.

Thousand Oaks, Ca, Us

Provided regulatory compliance and validation consulting and project management for multiple electronic data management (EDM) upgrades and implementations.

Principal Consultant providing Project Management, Quality System, Validation, and Compliance services.

Thousand Oaks, Ca, Us

Facilitated alignment of multiple IS Infrastructure project teams with corporate IS Program success criteria, milestones and manamement expectations.

New York, New York, Us

One 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.

Responsible 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.

London, Gb

Responsible 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.

Responsible 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.

Abbott Park, Illinois, Us

Responsible 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.