This position will be responsible for leading the Immunoassay (IA) Quality Control department for the manufacturing facility located in Shanghai. This includes staffing, developing, and training the IA Quality Control teams as well as supporting all activities to enable product transfer and plant readiness for product manufacturing, registration, launch, and continuous commercial production.
• Implementing strategic planning proposals for modeling Walpole Manufacturing operations within the Shanghai facility
• Developing the detailed Immunoassay Quality Control organizational structure to support product and production transfer and registration timelines
• Managing and providing oversight of the Quality Control department which includes Incoming Inspection, Microbiology, and In-Process & Final QC Release Testing
• Collaborating with Quality Assurance, Manufacturing, Technical Operations, Engineering and Technology Transfer to support facility needs
• Interacting with Walpole Operations and being responsible for production flow, operations process understanding, and business critical problem solving relating to:
o Immunoassay In-Process and Final Release Testing QC operations
o Incoming Inspection
• Creating job requisitions, interviewing, hiring of personnel
• Direct supervision and management of personnel
• Detailed written documentation of work
• Other related projects or tasks assigned by superior or company
Education and Experience:
• Bachelor’s degree or above in Chemistry, Pharmaceutical, Food science/Engineering, Biochemistry or related discipline or Diploma.
• An advanced/graduate degree or equivalent experience is preferred
• Typically 6+ years of successful experience in a directly related field and successful demonstration of Key Responsibilities and Knowledge as presented above (IVD experience a plus).
• Demonstrated Project and Personnel Management experience.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time