Process Management Support - Product Development / Process Management / Verification Manager / Diagnostics industry / GMP / English
Background
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.
The Perfect Candidate
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.
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
First experience in product development in a highly regulated environment is preferred (n2H)
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
Systematic mindset, able to understand complex concepts
Process experience
Flexible mindset, able to find solutions in situations which are not described in a process
Dealing with resistance
Experience in the Diagnostics industry and experience within the GMP regulated environment
Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing
German skills
Job Details
Reference Nr.: 924927
Rolle: Process Management Support
Industrie: Pharma
Location: Rotkreuz
Pensum: 100%
Start: Asap (01.09.2026)
Duration: 12+ months
Deadline: 12/05/2026
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