R&D Process Support Specialist

Roche Holding AG; Pleasanton (CA); On-site; USD 89,000 - 166,000; Full time

Job summary

Roche Holding AG in Pleasanton, California is seeking a Process Specialist to design, optimize, and harmonize development processes that support our product innovation and regulatory submissions. You will drive process management, coordinate with partners, and ensure regulatory documents are prepared for authorities such as FDA and TÜV throughout development and on-market support.

You will guide risk, requirements, configuration, and verification activities, maintain rigorous documentation, and

Qualifications

• Bachelor's or Master's degree in Natural Sciences or Engineering, or equivalent experience.
• 3+ years in a diagnostics development environment.
• Experience designing/executing development processes (risk, requirements, configuration, verification).
• Knowledge of software development, software validation, and related processes.

Responsibilities

• Design, develop, and optimize core R&D processes during product development and care activities.
• Guide and document process activities for product development and on-market support.
• Coordinate with internal/external partners and ensure regulatory compliance and complete documentation.
• Lead sub-projects and drive process improvements across units and projects.

Skills

Process design

Regulatory documentation

Stakeholder management

English communication

Project management

Education

Bachelor's or Master's in Natural Sciences or Engineering

Tools

Database software

Regulatory tooling

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

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.

Who You Are:

• 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.

Benefits

Who we are

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.