Position Overview: The Senior SAP Analyst, Quality Management is a critical member of the IT Corporate and Commercial Systems Team and reports to the Manager, IT Corporate Systems - Manufacturing Operations. Working in a dynamic, collaborative team environment, the successful candidate will support the Insulet Malaysia business operations in SAP S/4 HANA for Insulet\'s ERP Quality management through business processes definition, analysis of business problems, analytics, proposal/design/configuration/implementation of technical solutions, and continued development of the partnership with Insulet\'s Quality, Regulatory, and manufacturing organizations. The Senior Analyst will focus on projects and processes related to Malaysia Quality, Regulatory Management, and Manufacturing within SAP S/4 HANA, including incoming and in process inspection, inventory NCMR, regulatory country/region sales approvals, communication with third party sterilizers, and inter-relationships with Plant Maintenance processes. The ideal candidate will have a demonstrated ability to comprehend business process and context, while also having technical skills to design and configure appropriate technical solutions. Responsibilities: Perform complex business and systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. Develop supporting process flows. Conduct analysis of existing business processes; recommend process improvements. Support the build and implementation of new solutions in SAP S/4 HANA related to Quality, Regulatory, and manufacturing process improvements. Responsible for providing data expertise and consulting related to operational reporting and analytics. Develop training materials and conduct training sessions with business users to improve adoption and efficient use of all systems related to quality management functions. Create and manage workflows in SAP S/4 HANA as they pertain to business process. Assist in the evaluation of third party tools for feasibility and impact to the business. Support integrations between SAP S/4 HANA and external systems Create and maintain business requirement documentation which can include use cases, process flows, and system interface diagrams. Create design documentation based on business requirements. Communicate effectively with business users on the status of enhancements and projects. Develop comprehensive test plans with users, coordinate test activities and/or help execute test components. Perform other duties as required. Education and Experience: Bachelor\'s Degree and/or equivalent combination of education and experience. At least 5 years of experience working with SAP QM in a BA / Functional role Experience with S/4 HANA a plus At least 3 years of experience working on large projects or programs involving quality and regulatory management. Experience working in a highly regulated environment as well as International experience is strongly desired Ideal candidate will have knowledge of least the following systems and/or processes: Product compliance - Procurement and sales distribution quality management Incoming inspection planning, equipment, execution, and reporting for raw materials and finished goods In process inspection Inventory compliance Production and Production Planning a plus Plant Maintenance a plus Proven ability to provide business analysis and system development/configuration deliverables related to process improvement. Experience supporting or working with Quality, Regulatory, and manufacturing organizations, preferably in the pharmaceutical, medical device, or any other regulatory controlled industry. SAP S/4 HANA certifications preferred. Proven knowledge of the software and systems development life cycle. Knowledge of Data Warehousing, Reporting, and Statistical Analysis is a PLUS Skills/Competencies: Self-sufficient, flexible, and motivated team player capable of managing several activities simultaneously. Ability to work in a deadline focused, dynamic environment, and consistently produce deliverables within agreed upon timelines. Ability to analyze problems and develop solutions. Excellent communication, influencing and negotiating skills are critical. Ability to analyze business processes, design process improvements, and train business users on the new processes. Excellent writing skills. Must have the ability to express strategy, technical knowledge, and processes in easily understood presentations. Positive, results driven, rational, logical, team player. Ability to rapidly learn and take advantage of new concepts, business models, and technologies. Ability to work independently & on multiple projects against deadlines. Experience in the healthcare, pharma or medical device industry a plus. Multi-language fluency preferred (English, Malay) Physical Requirements: Less than 20% Travel
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