Process Manager
(m/f/d)
Freelance/temporary employment for a project Zug Start date: asap Reference number: 856810/1
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Responsibilities
1. Responsible for process guidance, process optimization and documentation of various development projects (systems and assays) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation Management, defects management and/or Usability Engineering
2. Support translation of multi-level requirements via Requirements Management process
3. Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives
4. Ensure all risks and requirements are maintained within a database and streamline approach across projects
5. Ensure the delivery of timely and good quality risk and requirements documentation
6. Establish and perform Configuration Management in complex development projects
7. Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
8. Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments
9. Information gathering from respective stakeholders including consolidation of information
10. Independent execution of work packages within area of responsibility; organize and manage their own time within scope of assigned work packages as well as ensuring the delivery of timely and good quality documentation
Profile
11. University degree in Life Sciences, Natural Sciences or Engineering
12. Good technical understanding of development processes
13. Excellent verbal and written communication skills in English, and preferably German in addition
14. Database experience preferred
15. Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing is advantageous
16. First experience in product development in a highly regulated environment is preferred (n2H)
17. Experience in the Diagnostics industry and experience within the GMP regulated environment is advantageous
18. Good analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teams
19. Ability to lead by influence, demonstrated effectiveness, drive decisions and account for results; ability to resolve conflicts and adapt to change, effective to drive results and achieve project goals
20. Excellent communication and presentation skills
21. Open minded team-player with an eye for details
Benefits
22. Fascinating, innovative environment in an international atmosphere
23. Extension: very likely with approved budget