Responsible for building and leading a team in China tasked with the transfer of immunoassay products to the China manufacturing site at both coordination and supporting execution level. This includes developing, staffing, and training the Technical teams in China as well as collaborating with the China Project Core Team & Technical group in Walpole to develop, staff, and execute the transfer plans as well as support activities to ensure plant readiness for product registration, launch, and commercial production.
Areas of Responsibilities
- Collaborating with the Walpole based Technical group to develop detailed Immunoassay product transfer plans to support product and production registration timelines.
- Supporting activities necessary to prepare for successful transfer of documents, test methods, manufacturing processes, etc. Including but not limited to transfer validation ,Change ,CAPA ,QN,TMD , investigation and CRB/VRB.
- Providing input into the creation of a process to coordinate with R&D, Walpole and the China site to ensure that newly developed assays are transferred successfully in the future.
- Develops and guides project/program solution plans. Implements technical projects or programs.
- Provides technical design guidance for projects or programs.
- Guides product manufacturing to ensure that cost effectiveness, manufacturability, quality, and safety requirements are attainable in the production process.
- Guides development of the accuracy and availability of procedures to support product modifications and assembly.
- /program management role (definition of schedule, risk, change, opportunity and resource allocation management)
- Guides continuous improvement plans and project/program expansion opportunities.
- Ensure completion of applicable training per Siemens Healthineers Quality standards to empower SHA Tech Ops becomes the Technical SMEs for all assay related issues.
- Typically 10+ years of successful experience in a directly related field (GMP and NMPA regulated environment, IVD experience a plus) and successful demonstration of Key Responsibilities and Knowledge as presented above.
- Demonstrated experience in managing international product transfers, generation and management of Gantt, SAP-PLM, change control and validation processes, BOMs and Routings a plus.
- BS/BA in Chemistry, Biochemistry, or related field.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time