Background
In her previous roles, Kimberly Lubragge ensured quality and compliance in support of organizational goals, regulatory requirements and quality process improvements. Extensive knowledge of quality training, data management, EDC/eQMS system development, computer system compliance, change control and validation; document management, project management, contractor/vendor qualification and auditing.
Education
Bachelor of Science, Health Care Management and Human Performance Management
Immaculata University, Immaculata, Pennsylvania (Magna Cum Laude)
Experience
Kimberly Lubragge began her career at a global medical devices company, where for 8 years she gained valuable industry experience in the areas of Quality Training, Clinical Data Management and Computer Systems Compliance. She then joined a small CRO in 2013 and spent 6 years as a Quality Assurance and Compliance generalist supporting document control, internal and external audits, clinical data management and the validation and administration of the electronic Quality Management system (eQMS). After a brief transition to a pharmaceutical manufacturing environment, Kimberly joined a global CRO for several years as a Process Designer for Document Control in the Quality Assurance department before joining MCRA in 2022.
Kimberly has specialized training and education in GCP, GMP, Clinical Research, Project Management, Data Management, Process Improvement, Inspection Readiness, Computer System Validation, UAT, Change Management, and multiple EDC and eQMS systems.
Overview
Kimberly Lubragge is an accomplished quality and compliance specialist with over 20 years of experience in project and quality system management. Areas of expertise include quality document and data management, computer system validation, change control and auditing. Kimberly is a cross functional team leader with a focus on achieving measurable quality results through continuous process improvement.
At MCRA, Kimberly is responsible for creating and managing quality initiatives and ensures the MCRA CRO quality management system remains in compliance with all relevant regulations, Good Clinical Practice (GCP) guidelines and company Standard Operating Procedures (SOPs). She is in charge of management and oversight of CRO Policies and SOPs, GxP computer system validation and maintenance, personnel training, and administration and development of the CRO eQMS system.