The Position Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
The Opportunity
The DSI Digital Innovation & Operational Services Chapter is a global team in R&D that focuses on internal improvement:
increasing productivity, efficiency, and improving the ability of the R&D organization to collaborate across its global organizational interfaces. Our work involves reducing complexity of our systems, harmonizing processes, tools, business practices and building connections across geographical and organizational silos.
You will become part of the R&D tool lifecycle management team that connects our diagnostics R&D through a common foundational toolset. As part of this team, you will primarily focus on all aspects of tool compliance, from tool acquisition, to system risks assessment and computerized system validation. Together with the whole team you will learn from and collaborate with our R&D customers across the globe and adopt our processes and tools according to the changing needs and environment. You will ensure the Roche internal development standards and best practices in all areas of the team.
You will work
* Supporting the business in specialized tool acquisitions and support in the management of the resulting licenses and by doing so ensure data consistency.
* Being a link between software projects, procurement departments, quality teams, Global IT departments and vendors.
* Managing software tools to ensure compliance in a regulated software development environment in collaboration with projects, Quality and Validation & Verification, and leading, managing and executing end-to-end Computerized System Validation (CSV) activities for systems of various complexity, ensuring GxP and other regulatory compliance.
* Conducting and overseeing detailed system risk assessments, establishing mitigation strategies and controls.
* Collaborating with internal customers to understand changing needs and their evolving R&D environment and exchange with internal IT and our supporting vendors where we get outside support;
managing long-term archiving of software releases (gold masters & source code) and supporting audits.
Who you are
* Bachelor’s or Master’s degree in a technical or business-related field.
* A track record in computerized system validation and tool and component lifecycle management.
* Leading roles in several developments of complex software solutions and participation in internal and external audits.
* Ability to communicate precisely and efficiently in English (C1 level);
German is a plus.
* Working experience in Healthcare or Medical Device software development environment is a plus.
Location:
Sant Cugat del Vallès (Hybrid Model)
Equal Opportunity
Roche is an Equal Opportunity Employer.
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