R&D Process Support Specialist

About the role

The Position As a Process Specialist within the R&D DCE Subchapter, you will play a key role in designing and optimizing various processes that support our development activities and product innovation. You will be responsible for driving, optimizing, and harmonizing development activities through future-oriented and efficient process management. You will also support or independently author regulatory documents provided to various authorities (including TÜV and the FDA).

Responsibilities

• Design, continuous development, and execution of core R&D processes (e.g., in line with Design & Development) during product development and product care activities, such as Requirements Management, Risk Management, and Configuration Management
• Design, continuous development, and execution of core R&D processes (e.g., in line with Quality & Verification) during product development and product care activities, such as Verification and Validation Management
• Guidance, execution, and documentation of process activities during product development as well as on-market support for established products
• Providing excellent process support to our internal and external partners
• Stakeholder management, coordinating alignments, and applying best practices and a unified approach across units and projects
• Ensuring full compliance and complete documentation according to internal guidelines
• Database mapping of respective processes and their contents (e.g., risk records)
• Proactive and independent execution of duties
• Ensuring defined project targets are met within established budgets, timelines, and quality requirements
• Executing various work packages within your area of responsibility, including effective time management
• Creating high-quality documentation
• Leading national sub-projects and contributing to ongoing process improvements
• Fostering future-oriented Ways of Working
• Acting as a role model and living our Roche Commitments regarding culture, behavior, and mindset
• Coaching colleagues to help expand and strengthen our team capabilities

Requirements

• You hold a Bachelor's or Master's degree in Natural Sciences or Engineering, OR an equivalent combination of degree and experience
• You bring at least 3 years of experience in a diagnostics development environment
• You have deep conceptual and practical experience in designing or executing development processes (e.g., Risk, Requirements, Configuration, or Verification Management)
• You have knowledge of software development, software validation, and associated processes
• You have experience working with databases and an eye for detail
• You have a solid understanding of the principles and methods of project and quality management is essential
• You have strong communication skills, including fluency in English, with the ability to explain complex technical issues clearly to non-technical stakeholders
• You have the ability to influence, drive decisions and change, resolve conflicts to reach project goals, and take ownership of outcomes
• You have strong customer orientation, an open-minded team spirit, and the agility to navigate ambiguity and frequent change effectively
• You are a natural leader with strong interpersonal skills, high emotional intelligence, and strategic thinking

Qualifications

• You hold a Bachelor's or Master's degree in Natural Sciences or Engineering, OR an equivalent combination of degree and experience
• You bring at least 3 years of experience in a diagnostics development environment
• You have deep conceptual and practical experience in designing or executing development processes (e.g., Risk, Requirements, Configuration, or Verification Management)
• You have knowledge of software development, software validation, and associated processes
• You have experience working with databases and an eye for detail
• You have a solid understanding of the principles and methods of project and quality management is essential
• You have strong communication skills, including fluency in English, with the ability to explain complex technical issues clearly to non-technical stakeholders
• You have the ability to influence, drive decisions and change, resolve conflicts to reach project goals, and take ownership of outcomes
• You have strong customer orientation, an open-minded team spirit, and the agility to navigate ambiguity and frequent change effectively
• You are a natural leader with strong interpersonal skills, high emotional intelligence, and strategic thinking

Skills

• Strong communication skills, including fluency in English, with the ability to explain complex technical issues clearly to non-technical stakeholders
• Ability to influence, drive decisions and change, resolve conflicts to reach project goals, and take ownership of outcomes
• Strong customer orientation, an open-minded team spirit, and the agility to navigate ambiguity and frequent change effectively
• Natural leadership with strong interpersonal skills, high emotional intelligence, and strategic thinking

Benefits

• Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.