PbProcess Management Support – Product Development / Process Management / Verification Manager / Diagnostics industry / GMP / English /b /p pbBackground: /bbr/The DCE CH subchapter is part of DSI within the Development Department of Roche Diagnostics in Rotkreuz (Switzerland). The main purpose of our subchapter is the support of development projects and product care activities with development processes like Requirement Management, Product Risk Management, Configuration Management and Defect Management. For this goal our team members are embedded into project teams and product teams, executing such processes by taking the responsibility of authoring the respective documents and ensuring that the processes are followed by the development teams. /p pbThe Perfect Candidate: /bbr/The typical Roche Diagnostics product consists of a combination of Hardware, Software, Plasticware and Biochemistry. The perfect candidate would have experience in developing/handling all these types of materials and understanding how they come together. Additionally the ideal candidate should be able to navigate in a dynamic project environment, where quite often exceptional situations occur. Efficient process management is not only working according to a checklist, but also understanding the product and project team with its challenges and issues and finding process solutions which keep the compliance and benefit the project. /p pbTasks Responsibilities: /bbr/* 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 Engineeringbr/* Support translation of multi-level requirements via Requirements Management processbr/* Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representativesbr/* Ensure all risks and requirements are maintained within a database and streamline approach across projectsbr/* Ensure the delivery of timely and good quality risk and requirements documentationbr/* Establish and perform Configuration Management in complex development projectsbr/* Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)br/* Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departmentsbr/* Information gathering from respective stakeholders including consolidation of informationbr/* Independent execution of work packages within area of responsibilitybr/* Organize and manage their own time within scope of assigned work packagesbr/* Ensure the delivery of timely and good quality documentation /p pbMust Haves: /bbr/* University degree in Life Sciences, Natural Sciences or Engineering br/* Good technical understanding of development processes br/* Excellent verbal and written communication skills in English br/* Database experience br/* First experience in product development in a highly regulated environment is preferred (n2H) br/* 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 br/* 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 goalsbr/* Excellent communication and presentation skillsbr/* Open minded team-player with an eye for details /p pbNice to Haves: /bbr/* Systematic mindset, able to understand complex conceptsbr/* Process experiencebr/* Flexible mindset, able to find solutions in situations which are not described in a processbr/* Dealing with resistancebr/* Experience in the Diagnostics industry and experience within the GMP regulated environment br/* Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing br/* German skills /p pbReference Nr.: /bbr/bRolle: Process Management Support /bbr/bIndustrie: Pharma /bbr/bLocation: Rotkreuz /bbr/bPensum: 100% /bbr/bStart: Asap ) /bbr/bDuration: 12+ months /bbr/bDeadline: 12/05/2026 /b /p pIf this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs(at)itcag(dot)com. br/Contact us for more information about our company, our positions, or our attractive payroll-only program: .br/About us:br/ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. /p