Senior Process Manager
Roche
This listing was originally posted on Roche's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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The Opportunity
As 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 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.
Lead Process Governance: Provide expert guidance and support for complex system, software, and assay projects across risk, requirements, configuration, and defect management.
Master Requirements & Traceability: Support multi-level requirements traceability and ensure all data is maintained within a streamlined, database-driven approach across projects.
Conduct Strategic Risk Assessments: Lead detailed product risk assessments by analyzing documents, reports, and market trends alongside cross-functional teams.
Establish Configuration Management: Build and maintain configuration management for complex projects, ensuring a clear overview of past, present, and future product states.
Ensure Regulatory Excellence: Provide specialized support to ensure that Verification & Validation (V&V) activities meet both internal standards and global regulatory requirements like ISO 13485.
Drive Radical Simplification: Proactively identify opportunities for process optimization and simplification to improve time-to-market without compromising quality.
Collaborate Globally: Thrive in an agile, multicultural setting where we experiment, learn, and trust each other to deliver the best results for patients.
You 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.
To be successful in this role, you bring:
Advanced Academic Foundation: A Master’s degree in Engineering, Life Sciences, Natural Sciences, or a related field.
Experience: Minimum of three years of experience in a regulated environment within product development or process management (Medical Device or Diagnostics industry preferred).
Technical Mastery: A strong understanding of Design Control processes and global standards such as ISO 13485 or IEC 62304.
Digital Fluency: Experience with ALM tools such as Jira, Azure DevOps, or specialized requirements management software is highly valued.
Exceptional Communication: Precise and efficient communication skills in English, enabling effective collaboration across our international sites.
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.
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