Process Management Support (m/f/d)  

As a first-tier supplier to our renowned business partner, Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Process Management Support for a temporary assignment of 12 months, with high probability of extension.

The DCE CH subchapter is part of DSI within the Development Department of Roche Diagnostics in Rotkreuz. The main purpose of the 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, 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 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 occur quite often. 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 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 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 the area of responsibility
• Organize and manage their own time within the 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
• 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

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen ? unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.