At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Business Process Quality Job Category: Professional All Job Posting Locations: Bogotá, Distrito Capital de Bogotá, Colombia Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for: COMMERCIAL QUALITY SPECIALIST FOR DISTRIBUTION CENTER in One J&J Bogota, Zona Industrial de Montevideo and Zona Industrial de Siberia (1 day per week in each site) Purpose: Responsible for supporting end-to-end quality operations within the Northern Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson MedTech. Establishing/maintaining quality assurance programs verifying that products meet their specifications and ensure that all elements of the quality management system follow the requirements of applicable local regulations. Provide support to the management of the Qualified Person (Technical Director) role. You will be responsible for: Coordinate and supervise the distribution centers, monitoring and ensuring the implementation of both corporate and local regulatory guidelines and standards. Support the implementation of company standards such as temperature control, loaner kit, and repack and relabel compliance, among others. Support regional business and QMS activities and processes when applicable. Provide support for the implementation and maturity of the quality management system, supporting Non-Conformances, CAPAs, and Change Controls processes, and ensuring correct implementation of other pillars of the quality management system in the Northern Cluster. Guide stakeholders of Commercial Quality in opening, executing, and following up on CAPAs, NC management, change control processes, and escalations per company standards. Support compliance with Good Practices and Regulations for Medical Devices aligned with EHS requirements and other policies within Distribution Centers. Report and display metrics/dashboards for quality indicators of Commercial Quality and 3PLs, with follow-up, analysis, and trend monitoring. Coordinate Gemba Walk tours at 3PL facilities and ensure timely follow-up of findings. Supervise product disposition processes in distribution centers. Support supervision and execution of Field Action and Stop Shipments processes. Lead, develop, and supervise the team when applicable. Participate and lead continuous improvement projects to enhance efficiencies, supporting Quality concepts and compliance. Support reporting to regulatory agencies (Pharmacovigilance and Techno-vigilance). Manage tools supporting the quality system (Designated Electronic System - DES). Participate in planning, executing, and receiving Quality audits (Internal, External, Regulatory). Ensure supplier management standards are met and quality agreements are renewed timely. Monitor regulatory compliance for logistics operators, including license renewals. Support and execute other activities as deemed appropriate by management. Provide technical advice regarding Medical Devices to legal and business areas, ensuring compliance with local regulations and leading continuous improvement projects. Support supplier and distributor selection processes specific to 3PLs. Approve procedures related to storage, conditioning, dispatch, and distribution when applicable. Maintain conditioning and storage facilities where Medical Devices are handled. Ensure traceability of Medical Devices through monitoring and control. Manage complaints and recalls of Medical Devices, monitor adverse events, and report to Health Authorities. Oversee inspection and packaging activities of Medical Devices when applicable. Maintain Medical Devices quality and represent J&J before Health Authorities when necessary. Qualifications / Requirements: Bachelor Degree in Pharmaceutical Chemistry, Biomedical Engineering, Surgical Instrumentation, Chemical Engineering, Industrial Engineering, or related fields. At least 5 years of experience in the pharmaceutical or medical device sector. Experience implementing elements of the Quality Management System in Distribution Centers (Third Party scope included). Experience leading Quality events such as Non-Conformities, CAPAs, Change Controls, etc., with Third Party Distribution Centers. Proficiency in technological tools like Power BI, Power Automate, etc., for process improvement. Experience leading projects and teams with cross-functional stakeholders. Upper Intermediate English proficiency. Portuguese language skills are a plus. #J-18808-Ljbffr