Description
Lead and manage all technical/laboratory/process activities and apply expertise to address complex design, development, operational issues and actively support DDC in decision making, strategies and goals by participating in cross-functional teams. Develop and implement long-term strategies on technologies, processes, medical devices and packaging related matters. Act as the Person-in-Plant (PIP) for Project-, Industrialization-, Qualification/Validation- and Supplier Management activitiesControl Strategy & Supplier management (CSSM):
1. Define the strategy, process, methods and tools for establishing a control strategy from end-to-end and implement this process, methods and tools.
2. Lead the establishment and implementation of best practices
3. Lead the establishment of standard operating procedures, work procedures, document templates and general guidance documents.
4. Coordinate input to internal and external audits and inspections
5. Maintain knowledge in the areas of Industrialization, Manufacturing, Checking and Control of medical devices and combination products.
6. Review design for manufacturing assessments, like mold flow , Design of Experiments (e.g. for OQ runs) and Design for Manufacturing and Assembly (DFMA)
7. Conduct activities and pursue audits for industrialization, qualification and validation of manufacturing processes for combination products and devices with/at suppliers & partners
8. Support project teams to prepare Medical Device/Combination Product pre- registration documents and provide input to answer health authority questions.
9. Conduct and oversee supplier management activities like Supplier Approval, Audits, Certification, Quality Risk Assessment, Quality Assurance Amendments, Evaluations, Development Agreements and supplier selection.
10. Lead activities to conduct CSSM tasks with suppliers & partners
11. Escalate and communicate status, issues and problems within the project with the management of suppliers and partners
12. Support Project leader in project management and communication activities with suppliers & partners
13. Act as the Person in Plant (PiP) for us at partners and suppliers