Thomas Spahn, Cqa Email & Phone Number

Columbus, Ohio, United States

• Acts as a liaison and subject matter expert supporting the Quality relationships with key suppliers and serves as the point of contact for quality related issues and documentation review and approval.• Establishes routine communication strategies for project tracking and prioritizations, drives continuous quality improvement projects across the enterprise for increased compliance. • Serves as escalation point of contact for key supplier Quality issues and work with internal and external cross-functional resources to identify concerns and ensure timely resolution of issues.

Dublin, Ohio

Provides Quality & Regulatory support to Cardinal warehouse and distribution facilities across North America.Internal Audit Coordinator for Medical and Pharmaceutical DistributionManages Global Approved Supplier ListPrepares and supports sites for various Governing Body Inspections (VAWD, CHAPS, ISO, FDA)Performs Quality Audits to Cardinal sites and Medical Device, OTC, and Cosmetic suppliersResponsible for the development and deployment of policies, procedures and programs at each site. ASQ Certified Quality AuditorISO 13485:2016 Lead Auditor Trained

Columbus, Ohio Area

• Overall responsibility for the performance of the Quality Assurance Department (30 direct reports), including safety, quality, production, and customer service. Reporting directly to this role are the QA Operations Managers, QA Technicians, and Product Release personnel.• Develops, manages and coaches operations managers and associates across all shifts to improve and build bench strength responsible for recruiting, training and retaining quality associates.• Formulation of Department strategy and annual goals and objectives that align with Production (OGSM – Objectives, Goals, Strategies, & Measures)• Achieving of Key Performance Indicators on the Plant Scorecard related to safety, quality, production and customer service levels.• Establish and maintain Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) related to the quality of our solid unit dose product line.

Dublin, Ohio

Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe, and effective.Conducts supplier quality audits, both domestically and internationally, to ensure drug product, OTC, medical device, and cosmetic products meet established requirements.Quality/Regulatory Leader for cross functional international (US, China, Singapore) project teams.

Columbus, Ohio Area & Bedford Ohio

Mentored group of 5 investigations specialists• Lead Investigator• Lead auditor• Managed relationships with third party suppliers.• Direct suppliers to ensure products are produced in accordance with FDA / cGMP standards.• Approve supplier quality assurance investigations for out of specification (OOS), out of trend (OOT), stability, customer complaint, and all other atypical events.• Facilitate and review the approval of change control (including Corporate), equipment qualifications, and production support for third party products.

B.S., Biology

M.B.A., Finance