Paola Marcela Fletscher Covaleda
Director of Continuous Improvement and Innovation @Amgen
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WORK HISTORY
Director of Continuous Improvement and Innovation @Amgen
Thousand Oaks, CA, US
Responsible for assessing, monitoring and continuously improving the Quality Management System processes within Amgen R&D to ensure these processes are efficient, industry leading and fit for purpose for the end user. Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for Amgen R&D. Lead, collaborate and partner with internal R&D team members to analyze and resolves issues and risks to drive clear scope, sponsorship, planning and execution. Lead and support management directed projects based on data driven from either Management Review or QMS trending or ad-hoc individual quality events that are of large impact/scope and thus risk for Amgen clinical trials and pre-clinical research activities. Set strategy, standards and performance expectations for R&D QMS Business Process Owners in Partnership RDQ Leadership Team. Participate, conduct, lead industry collaborations aimed to advance Amgen’s QMS within R&D. Lead Continuous Improvement / Root Cause Analysis in response to improvement opportunities resulting from inspections and or audits.Key Achievements:• Lead the design and implementation of the Audits and Inspections, Serious Breaches, and Planned Deviations modules in the new Amgen Quality Management System.• Design and implementation of Yellow Belt training for all R&D Quality staff.• Establishment of the continuous improvement and change management team for R&D Quality.
EDUCATION
Universidad Santo Tomas
Especialista en Auditoria de la Salud, Auditoria de Salud
Universidad Nacional de Colombia
Magister en Ciencias - Farmacologia, Farmacología
Universidad Nacional de Colombia
Diplomado Aspectos Regulatorios, Buenas Prácticas Producción y Farmacovigilancia Medicamentos Biotec
Universidad Nacional de Colombia
Química Farmacéutica, Farmacia
Universidad de Buenos Aires
Maestría en Efectividad Clínica, Efectividad Clínica y Sanitaria
Fundación Universitaria de Ciencias de la Salud
Diplomado de Farmacoterapia
Universidad de Alcalá
Master's degree, Pharmacovigilance
SKILLS
ABOUT PAOLA MARCELA FLETSCHER COVALEDA
Pharmacist, Master in Pharmacology, Master in Pharmacoepidemiology and Pharmacovigilance, Specialist in Health Auditing and aspiring Master of Clinical Effectiveness with emphasis on Health Technology Assessment, with a high sense of responsibility, ability to work in teams, leadership, decision making, experience in management teams and troubleshooting.15 years of experience in the pharmaceutical industry leading pharmacovigilance, compliance, and pharmaceutical care programs, with solid knowledge of international regulations. Leader in the management of regulatory inspections for GPvP and GCP by various reference entities such as FDA, MHRA, TGA, EMA, and Health Canada.Knowledge and experience in root cause analysis, deviation management, CAPA implementation, and effectiveness verification, focused on continuous improvement and process innovation.
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