Process Management Support

Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our longstanding client, Roche Diagnostics International AG in Rotkreuz, we are looking for a

DescriptionBackground:

The DCE CH subchapter is part of DSI within the Development Department of Roche Diagnostics in Rotkreuz, Switzerland. Our subchapter's main purpose is to support development projects and product care activities with development processes like Requirement Management, Product Risk Management, Configuration Management, and Defect Management. Our team members are embedded into project and product teams, executing these processes by 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 exceptional situations often occur. Efficient process management is not only about working according to a checklist but also understanding the product and project team with its challenges and issues and finding process solutions that maintain 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 with a team of cross-functional representatives
• Ensure all risks and requirements are maintained within a database and streamline the approach across projects
• Ensure the delivery of timely and high-quality risk and requirements documentation
• Establish and perform Configuration Management in complex development projects
• Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
• Manage project-related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers, and other internal departments
• Gather information from respective stakeholders including consolidation of information
• Independently execute work packages within the area of responsibility
• Organize and manage your own time within the scope of assigned work packages
• Ensure the delivery of timely and high-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
• Good analytical thinking, structured, reliable working manner, ability to prioritize, plan and manage multiple tasks, and instill a sense of urgency in teams
• Ability to lead by influence, demonstrating effectiveness, driving decisions and accountability for results, ability to resolve conflicts and adapt to change, effective in driving results and achieving project goals
• Excellent communication and presentation skills
• Open-minded team player with an eye for detail

Nice to Haves:

• Systematic mindset, able to understand complex concepts
• Process experience
• Flexible mindset, able to find solutions in situations not described in a process
• Experience dealing with resistance
• Experience in the Diagnostics industry and within the GMP regulated environment
• Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing
• German skills

What We Offer:

• An opportunity to contribute to one of the world's leading pharmaceutical companies
• A modern campus with green spaces and social areas
• Central location with motorway access and nearby train station
• Diverse activity profile
• Home office possibilities
• Continuing education opportunities through temptraining
• Teamwork in a dynamic and motivated team
• Competitive compensation

Please send your complete application documents to Mr. Severin Räfle.