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Sant Cugat del Vallès, Catalunya, España
Onsite
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.
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
Risk 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 configurations.
Defect Management: Support with defect management by creating the defect management plan and managing defects.
Verification & Validation: Provide support to ensure that V&V activities are planned, executed and documented according to our internal procedures.
Continuous Improvement: Identify opportunities for process optimization and "radical simplification" to improve time-to-market without compromising quality
You are a proactive and service-oriented professional who excels at analytical thinking, problem-solving, and precise communication. You possess a collaborative mindset and are excited to grow your skills in a dynamic environment where we experiment and learn together.
To be successful in this role, you bring:
Educational Foundation: A Bachelor’s degree in Engineering, Life Sciences, Natural Sciences, or a related field.
Regulated Industry Expertise: A minimum of three years of professional experience in a regulated product development environment (or a Master's degree), with preferred exposure to the Medical Device or Diagnostics industry.
Technical Process Mastery: A understanding of Design Control processes and relevant global standards, such as ISO 13485 or IEC 62304.
Digital Fluency: Familiarity with ALM tracking systems (such as Jira, Azure DevOps, RETINA, or HP ALM) is considered a plus.
Exceptional Communication: Clear, precise, and efficient communication skills in English; knowledge of Spanish is a valuable asset.
There are 2 positions of this role.
At Roche, you’ll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together.
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.
Roche is an Equal Opportunity Employer.
