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).

The Opportunity:

• 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.

• Execution of various work packages within your area of responsibility, including effective time management.

• Creation of 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.

• 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.

Relocation benefits are not available for this position.

The expected salary range for this position based on the location of Pleasanton, Californiais $89,400 to $166,000.  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.