Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing customer, Roche Diagnostics International AG in Rotkreuz, we are looking immediately for a
Process Manager
Background:
The Department Design Control Excellence CH is looking for a process manager with a good understanding of IVD product development processes. The process manager is responsible for process guidance, process optimization and documentation of various development projects.
Tasks & Responsibilities:
* 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
* Support translation of multi-level requirements via Requirements Management process
* Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives
* Ensure all risks and requirements are maintained within a database and streamline approach across projects
* Ensure the delivery of timely and good quality risk and requirements documentation
* Establish and perform Configuration Management in complex development projects
* Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
* Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments.
* Information gathering from respective stakeholders including consolidation of information
* Independent execution of work packages within area of responsibility
* Organize and manage their own time within scope of assigned work packages
* Ensure the delivery of timely and good quality documentation
Must Haves:
* University degree in Life Sciences, Natural Sciences or Engineering
* Good technical understanding of development processes
* Excellent verbal and written communication skills in English
* Database experience preferred
* Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing is a plus
* First experience in product development in a highly regulated environment is preferred (n2H)
* Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus
* 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
* 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
* Excellent communication and presentation skills
* Open minded team-player with an eye for details
Nice to Haves:
* German
What you are offered:
* Modern campus with plenty of green spaces and meeting zones
* Central location with highway access and train station nearby
* Varied job profile
* Home office option up to 50%
* Further training opportunities through temptraining
* Working in a dynamic and motivated team of 28 people
* Good remuneration
You are welcome to send your complete application documents to Mr. Severin Räfle.
Fulltime Vollzeit Diagnostik Forschung Entwicklung Prozessingenieur Produktingenieur Projektmanager Zentralschweiz
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