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 aProcess ManagerBackground: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 EngineeringSupport translation of multi-level requirements via Requirements Management processConduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representativesEnsure all risks and requirements are maintained within a database and streamline approach across projectsEnsure the delivery of timely and good quality risk and requirements documentationEstablish and perform Configuration Management in complex development projectsSupport 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 informationIndependent execution of work packages within area of responsibilityOrganize and manage their own time within scope of assigned work packagesEnsure the delivery of timely and good quality documentationMust Haves:University degree in Life Sciences, Natural Sciences or EngineeringGood technical understanding of development processesExcellent verbal and written communication skills in English Database experience preferredExperience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing is a plusFirst 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 plusGood analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teamsAbility 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 goalsExcellent communication and presentation skillsOpen minded team-player with an eye for detailsNice to Haves:German What you are offered:Modern campus with plenty of green spaces and meeting zonesCentral location with highway access and train station nearbyVaried job profileHome office option up to 50%Further training opportunities through temptrainingWorking in a dynamic and motivated team of 28 peopleGood remunerationYou are welcome to send your complete application documents to Mr. Severin Räfle.Fulltime Vollzeit Diagnostik Forschung Entwicklung Prozessingenieur Produktingenieur Projektmanager Zentralschweiz jid7d4e773a jit0103a jiy26a