Commercial Quality Shared Service (CQSS) is the global J&J organization responsible for Quality support to the commercial operations mainly for transportation for all J&J sectors, in full compliance with health authority regulations and the J&J Quality Standards. This position serves as a single point of contact to the operational partners on Transportation & Temperature Control Quality Management in Asia Pacific, which provides cost effective services to all three segments, leveraging common processes, procedures, and resources, globally and in each region

Responsible for execution of Quality Management System elements applicable to distribution center operations and distributors in SEA countries that receive, pick, pack, store, inspect, and deliver finished goods to customers, retailers, wholesalers, and distributors.A. Distribution and Inventory Management Process; - Oversee quality process for distribution and inventory management activities at DC and Distributor- Implement quality standard (Temperature Controlled, Repack-Relabel and Loaner Kit) activities in compliance with enterprise standard/procedure.- Support execution and Follow-up all product quality holds and field actions in distribution center/s.- Accurate and timely communication of temperature control excursions and seek product disposition decision and implement.- Provide Quality input and oversight on distribution network changesB. Quality Management System- Provide support to the implementation and improvement of QMS - Ensure appropriate handling of distribution complaints includes Track and trend, Report and mitigation plans.- Support implementation of Quality/Operation improvement programs- Work and train team on Quality system platforms C. Compliance; Ensure related standards are effectively implemented/ Manage Health Authority inspections at DC/ Manage/Support JJRC audit/ Timely and accurate metrics reporting in Curve/ Roll-out goals and objectives for team members in line with regional goalsD. Distribution Supplier Quality Management which include selection, qualification, audit and monitoring process for distribution center, distributor plus, logistics and transportation. Provide Quality input and oversight on distribution network changes

•Support the cross-functional implementation plan for purchasing controls at CLS sites within the operating region •Directly lead the quality aspects of the purchasing controls implementation plan, to ensure consistency in approach between sites in the region•Provides routine progress reporting and takes action where goals and timelines are at risk•Act as an implementation subject matter expert, providing standards, tools and guidance for these sites and actively serving and supporting the sites’ implementation plans in a hands-on manner•Maintain and optimize risk assessment tools, processes and criteria for impact (risk) segmentation of CLS suppliers in alignment with Enterprise efforts•Maintain and optimize standard supplier selection and qualification tools and processes for CLS suppliers in alignment with Enterprise efforts•Develop and maintain the annual CLS service provider audit calendar for the region •Perform physical and desktop quality audits and assessments of suppliers providing products and services to CLS•Coordinate internal and external audit resources to ensure timely execution of the regional CLS supplier audit program•Directly support Distribution Center sites during 3rd party audit and Health Authority inspections, particularly with respect to defense of the sites’ supplier quality programs and results

•Implement and evaluate a highly effective Q&C Function & Awareness within Customer Logistic & Service ASEAN Community - cross sectors•Independently partner with ASEAN business quality, Regional Customer Logistic & Service, Distribution Center quality and operational leader as well as other affiliate for Q&C Customer Logistic & Service•Close collaboration with business quality, local regulatory team, Supply and Distribution Center•Deploy new standard/ requirement to Distribution Center, conduct training to Distribution Center partner and ensure compliance of new standard/requirement deployment•Manage third parties re-packer quality system & activities in compliance with GMP, local regulatory and J&J standards. Ensure re-dresses activities third party re-packer meet quality and regulatory compliance•Conduct yearly audit with Distribution Center and re-packer in accordance to local FDA regulatory, J&J requirements, GMP, Safety Health, and Environmental and cooperate quality standard. Identify gap and make recommendation on improvement. Lead assigns team to develop audit action plan & gap closure with Distribution Center and re-packer for execution•Lead an assigned team to investigate the non-conformance, deviation and consumer complaint in quality aspect. Propose suitable action plan for problem solving. Provide necessary technical and quality support to execute the action plan. And assess effectiveness of corrective actions/preventive action•Coordinate with affiliate countries to solve quality problem from transportation to Distribution Center

•Manage Q&C system, process in Sale and Marketing Company according to Local FDA regulatory, J&J policy and requirement, regional procedures and GMP related standards•Develop process and implement Q&C system thought out the Sale and Marketing Company and at business partner in Thailand, Laos, Cambodia & Myanmar•Deploy new standard/ requirement to Sale and Marketing Company. Conduct training to sale & marketing partner and ensure compliance of new standard/requirement deployment•Manage new product introduction (Thailand, Laos, Cambodia & Myanmar marketed product) for quality perspective. Provide recommendations in project execution to ensure local regulatory requirement and J&J standard compliance•Manage 3rd parties co-packer quality system & activities in compliance with GMP, local regulatory and J&J standards. Ensure re-dresses activities third party co-packer meet quality and regulatory compliance•Conduct yearly audit with Distribution Center, Distributor and co-packer in accordance to Thai-FDA regulatory, J&J requirements, GMP, Safety Health, and Environmental and cooperate quality standard. Identify gap and make recommendation on improvement. Lead assigns team to develop audit action plan & gap closure with Distribution Center, Distributor and co-packer and execution•Lead an assigned team for internal and external audit activities. Proposes suitable corrective action and preventive action to auditor. And follow up audit action plan to close on time•Lead an assigned team to investigate the NC, deviation and consumer complaint in quality aspect. Propose suitable action plan for problem solving. Provide necessary technical and quality support to execute the action plan. And assess effectiveness of corrective actions/preventive action•Coordinate with affiliate countries to solve quality problem with imported product marketed in Thailand•Generate Q&C monthly report in accordance with Regional KPI and provide gap closure proposal

•Ensure all powder manufacturing line are complied with good quality procedure and all F/G are released without quality problems•Conduct and execute process, mixing and C&S validation for powder product and issue report for NPD, CIP, Engineering and production improvement project for powder to support product launch on time. And ensure quality and compliance of product during validation•Lead an assigned team to investigate the cause of production/ product failure in technical and quality aspect. Propose suitable action plans for production/ product failure problem solving. Provide necessary technical and quality support to execute the action plans•Conduct investigation and develop proper corrective actions for consumer complaint handling regarding powder products and verify the action plans and effectiveness•Conduct training to operation staffs for powder such as FG inspection under PSI program (Production Self Inspection), Cleaning & Sanitization process and GMP Work with Operation to ensure NC and CAPA closed on time and verify the action plans and effectiveness•Act as contact person in term of quality problem’s solving to support the requirement from affiliate countries. Ensure all FAI(s) are passed the acceptance criterion and get approval from affiliated countries before product released•Conduct/ support quality improvement program e.g. GMP audit, PSI, SPC and Zero defect program for all powder manufacturing lines and ensure action plans are closed•Support for internal and external audit including closing gaps from the audit•Coordinate to conduct microbial risk assessment with microbiologist for Powder lines and lead to develop action plan and follow up to close the gaps, for ensuring the robustness of micro green site

•Develop vendor activities at co-manufacturing by making recommendations on quality improvements and requirements.•Measure and monitor vendor performance according to the standard and requirements•Manage risks assessment in terms of food safety, environment, and traceability which include annual audits, supplier developments and etc•Conduct weekly product panel reviews and quality control checks at co-manufacturers for shipments to all markets•Investigate customer complaints, trouble shoot quality issues and perform complaint trending•Generate co-manufacturer’s quality reports•Conduct line trials and commissioning runs at suppliers for new products/materials•Develop material risk assessments and specifications with customer units