Roche
Diagnostics
ProcessManager
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“Process Manager at Roche. Skills: Process Management, Cross-functional Coordination, Vendor/Stakeholder Management. Provide process guidance and support. Support the creation and maintenance of product requirements”
What You'll Achieve.
ensure our life-saving diagnostic products are safe, effective, and compliant; secure compliant execution; improve time-to-market without compromising quality
Industry & Context.
analytical thinking; problem-solving
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Life Sciences, Natural Sciences, or a related field, minimum of three years of professional experience in a regulated product development environment (or a Master's degree)
Nice to Have
preferred exposure to the Medical Device or Diagnostics industry, Familiarity with ALM tracking systems (such as Jira, Azure DevOps, RETINA, or HP ALM)
What You'll Do.
Provide process guidance and support
Support the creation and maintenance of product requirements
Support execution of product risk assessments
Establish and maintain Configuration Management
Support with defect management
Provide support to ensure V&V activities
Identify opportunities for process optimization
How You'll Work.
Team & Collaboration
work in a cross-functional environment; collaborative mindset
Communication Scope
Clear, precise, and efficient communication skills; knowledge of Spanish is a valuable asset
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position ### The Opportunity As a **Process Manager** within our Design Control Excellence (DCE) team in Sant Cugat, you will be responsible for the essential development processes that ensure our life-saving diagnostic products are safe, effective, and compliant. You will play a key role in the execution of Requirement Management, Product Risk Management, Configuration Management, Defect Management and Verification & Validation within development projects. Joining a growing innovation hub, you will work in a cross-functional environment to secure compliant execution while continuously optimizing process efficiency to meet evolving organizational needs. **Key Responsabilities** * **Process Support:** Provide process guidance and support for system, software, and assay projects with low complexity across Risk, Requirements, Configuration, Verification & Validation and Defect Management. * **Product Requirements:** Support the creation and maintenance of product requirements by using the respective IT tool. Ensure that the appropriate documentation is created and are responsible for obtaining approval from the stakeholders.Facilitate and maintain the requirements traceability throughout the development of the product * **R isk Assessment:** Support execution of product risk assessments. Create and maintain respective risk documentation. * **Configuration Management :** Establish and maintain Configuration Management for projects, maintaining a clear overview of past, present, and future product configura
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