Roche

SeniorProcessManager

Spain FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior Process Manager at Roche. Skills: Process management, Cross-functional coordination, Vendor/stakeholder management, Operational metrics. Provide expert guidance and support for complex system, software, and assay projects. Support multi-level requirements traceability”

What You'll Achieve.

Ensure life-saving products are safe, effective, and compliant; Ensure compliant execution; Continuously optimizing efficiency; Improve time-to-market without compromising quality; Deliver the best results for patients

Industry & Context.

Problems you'll solve

Solving complex problems independently; Analytical thinking

What They're Looking For.

Must Have

Minimum of three years of experience in a regulated environment within product development or process management, Master’s degree in Engineering, Life Sciences, Natural Sciences, or a related field, A understanding of Design Control processes and global standards such as ISO 13485 or IEC 62304, Precise and efficient communication skills in English

Nice to Have

Medical Device or Diagnostics industry preferred, Experience with ALM tools such as Jira, Azure DevOps, or specialized requirements management software is highly valued

What You'll Do.

Provide expert guidance and support for complex system

Support multi-level requirements traceability

Lead detailed product risk assessments

Build and maintain configuration management for complex projects

Provide specialized support to ensure that Verification & Validation (V&V) activities meet both internal standards and global regulatory requirements

Identify opportunities for process optimization and simplification

How You'll Work.

Team & Collaboration

Work in a cross-functional environment; Collaborate globally; Collaborate across our international sites

Communication Scope

Precise and efficient communication skills in English

Process & Methodology

Manage complex development projects, Manage requirements, Manage risk, Manage configuration, Manage defects

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 **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 regu

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