Senior Design Control & Process Leader
hace 2 días
Sant Cugat del Vallès
ppAt 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. /p h3The Position /h3 h3The Opportunity /h3 pAs a Senior 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 products are safe, effective, and compliant. You will play a key role in executing requirement, risk, configuration, defect management, and verification validation within complex development projects. This is an opportunity to join a growing innovation hub where you will work in a cross‑functional environment to ensure compliant execution while continuously optimizing efficiency to meet evolving organizational needs. /p ul liLead Process Governance: Provide expert guidance and support for complex system, software, and assay projects across risk, requirements, configuration, and defect management /li liMaster Requirements Traceability: Support multi‑level requirements traceability and ensure all data is maintained within a streamlined, database‑driven approach across projects /li liConduct Strategic Risk Assessments: Lead detailed product risk assessments by analyzing documents, reports, and market trends alongside cross‑functional teams /li liEstablish Configuration Management: Build and maintain configuration management for complex projects, ensuring a clear overview of past, present, and future product states /li liEnsure Regulatory Excellence: Provide specialized support to ensure that Verification Validation (VV) activities meet both internal standards and global regulatory requirements like ISO 13485 /li liDrive Radical Simplification: Proactively identify opportunities for process optimization and simplification to improve time‑to‑market without compromising quality /li liCollaborate Globally: Thrive in an agile, multicultural setting where we experiment, learn, and trust each other to deliver the best results for patients /li /ul h3Who You Are /h3 pYou are a proactive and service‑oriented professional who excels at solving complex problems independently. You bring strong analytical thinking and the ability to communicate precisely in a collaborative, global environment. /p h3To be successful in this role, you bring: /h3 ul liAdvanced Academic Foundation: A Master’s degree in Engineering, Life Sciences, Natural Sciences, or a related field /li liExperience: Minimum of three years of experience in a regulated environment within product development or process management (Medical Device or Diagnostics industry preferred) /li liTechnical Mastery: A strong understanding of Design Control processes and global standards such as ISO 13485 or IEC 62304 /li liDigital Fluency: Experience with ALM tools such as Jira, Azure DevOps, or specialized requirements management software is highly valued /li liExceptional Communication: Precise and efficient communication skills in English, enabling effective collaboration across our international sites /li /ul pThere are 2 positions of this role. /p pAt 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. /p h3Who we are /h3 pA 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. /p pLet’s build a healthier future, together. /p pRoche is an Equal Opportunity Employer. /p /p #J-18808-Ljbffr