Responsible for implementing and maintaining the effectiveness of the quality system at the Abbott Irving facility. This includes developing the annual audit schedule for the site, assigning audit support personnel based on audit schedule and the agreement of site management, and leading inspection/audit readiness activities and communicating progress and opportunities with the senior site leadership.

 Address potential audit gaps and associated corrections as a member of the site inspection readiness team. Delegated as a point of contact for Technical Product Development related matters during internal/external inspections. Experienced in external audits including a multiple ISO MDSAP audits, a USDA inspection, and a supporting role in an FDA general inspection. Serve as a SME with direct interaction with auditors during internal corporate and division level audits. Interviewed by previous FDA leaders as part of inspection readiness, receiving positive feedback from each. Traveled as part of a compliance team to assist an international manufacturer with a pending FDA inspection, yielding a successful audit result. Worked with third party manufacturers as part of the Field Action Reduction Project, identifying potential field action sources in a GMP manufacturing area. Assigned to the Global CAPA Steering Committee, reviewing CAPA with potential to impact other Abbott worldwide locations. Review site critical CAPA on a weekly basis as part of the site CAPA management review. Document and manage CAPA activities related to the Technical Product Development group, ensuring required actions are completed per assigned timelines. Implemented mean kinetic temperature (MKT) approach into the laboratory-controlled temperature unit procedure, reducing related CAPA related occurrences for one freezer from 27 to 0 over a year’s time.  Continuing leadership development by completing Abbott sponsored training for Dallas Manager Development, Situational Leadership, and Lean Leadership.

 Provided technical leadership for the transition of 12 Abbott owned clinical chemistry reagents and calibrators between two third party manufacturers. Reviewed and assessed over 40 validations, verifications and equipment qualifications associated with a clinical chemistry reagent site transfer, including the validation of a new filling and labeling line, verification of test methods at the new site, and qualifications of multiple walk-in cold rooms and freezers. Recommended by management to be part of a site improvement project team at a third party manufacturer, reviewing manufacturing filtration processes and microbial testing methods.

 Provided Quality oversight for the transition of 62 clinical chemistry reagents from an internal manufacturing facility to a third party manufacturer. The transfer included items such as manufacturing processes/validations, new raw material validations, test method validations, labeling updates, and incoming product specifications. Performed domestic and international external supplier audits as a certified lead auditor, inspecting suppliers per ISO 13485 and 21 CFR 820 requirements.

 Provided Quality system oversight and management, serving as the Quality lead for the company.  Developed the Quality system from the ground up using current federal regulations and guidances. Managed headcount at multiple locations, including one international site. Served as the primary contact for written communications from the FDA. Authored the CMC section of an IND for a Phase I nasal powder vaccine, as well as drug master files and their annual amendments. Provided Quality oversight for GMP production activities. Created and implemented the CAPA program for the company. Designed and established a stability program based on ICH guidelines (Q1). Interacted regularly with commodity and service suppliers, including regulatory consultants, medical device suppliers, clinical research principal investigators, and preclinical study directors as well as varying levels of management within the company. Designed, built, maintained and monitored a Class 10,000 (ISO 7) clean room used for pilot-scale manufacturing operations, including the development of environmental testing and maintenance procedures.