Process Manager

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 a

Process Manager

Background :

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 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 preferred

Experience in Process Management (Risk- Requirements- Configuration- and / or Verification Management) or Product Development such as testing is a plus

First 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 plus

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 :

German

What you are offered :

Modern campus with plenty of green spaces and meeting zones

Central location with highway access and train station nearby

Varied job profile

Home office option up to 50%

Further training opportunities through temptraining

Working in a dynamic and motivated team of 28 people

Good remuneration

You are welcome to send your complete application documents to Mr. Severin Räfle.

Fulltime Vollzeit Diagnostik Forschung Entwicklung Prozessingenieur Produktingenieur Projektmanager Zentralschweiz

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