Process Manager
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, hosting important research and development functions. We are currently seeking a dedicated Process Manager for our long-standing customer, Roche Diagnostics International AG in Rotkreuz.
Background
The Department of Design Control Excellence CH is looking for a process manager who possesses a solid understanding of IVD product development processes. The process manager will be responsible for guiding processes, optimizing workflows, and documenting various development projects.
Tasks & Responsibilities
- Provide process guidance, optimization, and documentation for various development projects (systems and assays) focusing on Requirements Management, Risk Management, Configuration Management, Verification and Validation Management, defects management, and Usability Engineering.
- Facilitate the translation of multi-level requirements through the Requirements Management process.
- Conduct detailed risk assessments by analyzing documents, statistics, reports, and market trends in collaboration with a team of cross-functional representatives.
- Ensure all risks and requirements are tracked in a database and promote a streamlined approach across projects.
- Deliver timely and high-quality risk and requirements documentation.
- Establish and perform Configuration Management for complex development projects.
- Support development projects as Verification Manager, including planning, guiding, training, and 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 stakeholders and consolidate it effectively.
- Execute work packages independently within the area of responsibility.
- Organize and manage time efficiently within the scope of assigned work packages.
- Ensure timely delivery of high-quality documentation.
Must Haves
- University degree in Life Sciences, Natural Sciences, or Engineering.
- Strong technical understanding of development processes.
- Excellent verbal and written communication skills in English.
- Experience with databases is preferred.
- Background in Process Management (Risk, Requirements, Configuration, and/or Verification Management) or Product Development is an advantage.
- Experience in a highly regulated environment (e.g., n2H) is preferred.
- Familiarity with the Diagnostics industry and exposure to a GMP-regulated environment is a plus.
- Solid analytical thinking skills, a structured and reliable work ethic, and the ability to prioritize, plan, and manage multiple tasks effectively.
- Ability to lead through influence, drive decisions, and provide results; adept at conflict resolution and adapting to change.
- Outstanding communication and presentation skills.
- An open-minded team player with a keen eye for detail.
Nice to Haves
What You Are Offered
- A modern campus with abundant green spaces and collaborative meeting areas.
- A central location with easy access to highways and nearby train stations.
- A diverse job profile with opportunities for growth.
- Home office options available up to 50% of the time.
- Further training opportunities through temptraining.
- Work in a dynamic and motivated team of 28 professionals.
- Attractive remuneration package.
Apply online using the form below. Please note that only applications matching the job profile will be considered.