Quality management, and oversight processes within Korea under his/her responsibility. • Ensure implementation of and on-going compliance with applicable regulatory requirements for all GxP areas i.e. GMP, GDP and the Bracco Code of Ethic, Policies, and Quality Guidelines as well as with Industry Best Practices and that non-compliance is appropriately addressed via Corrective and Preventive Actions (CAPA) and/or escalation of issues. • Design, implementation and maintenance a Quality Management System to assure pharmaceutical products and medical devices quality in commercial affiliate and supply chain. • Drive together with the Commercial Affiliates Quality Units and the Commercial Affiliates Head the creation and implementation of a consistent quality culture across countries in the respective region. • Support quality activities in supply chain and traceability of products in Korea. • Drive the implementation of the Regional Quality Organization on local level. Ensure implementation of applicable Quality Standards and governance processes through the implementation of the Bracco Policies and Quality Guidelines. • Ensure implementation of defined Key Compliance / Quality Indicators KC/QI in the region to monitor on an on-going basis that relevant processes are in control and compliant as well as that regulatory controls are in place in relevant process steps. • Regularly review and assess KC/QIs of the concerned region. Ensure that potential compliance gaps and risks are addressed and opportunities for continuous improvement identified and the annual Regional Quality Plan implemented in the countries. • Provide quality oversight for deviations, investigate root cause and ensure real root causes are clearly identified and adequate CAPA’s are implemented. • Provide quality oversight for change control process to ensure all local changes are compliant to GMP and company guideline. • Provide quality oversight in complaint handling and product recall, investigate root cause, ensure related procedure are strictly implemented and quality events are successfully solved. • Liaise effectively across e.g. TechOps Supply-Chain, Regulatory Affairs and Procurement to ensure that global processes are adequately implemented and projects are successfully launched in the countries. • Ensure that proper Quality oversight is implemented in countries for 3rd parties/vendors/outsourced activities. • In liaison with the local GM&RA Ensure effective communication with local Health Authority is adequately shared within the organization and commitments tracked and closed on time, including coordination of product recall, issue of new regulation and submission of changes to Health Authority. Inform CQM about all the requests or regulatory alert fields by the local regulatory agencies; • Prepare and implement Health Authorities Inspection, Internal Corporate Audit and Third Party audits • Support RA manager for various global and local RA&QA projects • Management of local product labeling to comply with local regulations and update timely