R&D Process Lead: Development & Compliance

Biopharma Careers; United States; On-site; USD 89,000 - 166,000; Full time

Job summary

Roche in Pleasanton, CA seeks a Process Specialist to design, optimize core R&D processes and manage development activities, including requirements, risk, and configuration management. You will support regulatory document creation for authorities and lead sub-projects across units, ensuring compliance and strong stakeholder collaboration.

The role emphasizes process excellence, cross-functional teamwork, and mentoring colleagues while driving future-oriented ways of working within Roche.

Qualifications

• Bachelor's or Master's degree in Natural Sciences or Engineering or equivalent experience.
• At least 3 years of diagnostics development experience.
• Experience designing or executing development processes (risk, requirements, configuration, verification).

Responsibilities

• Design and optimize core R&D processes across product development and care activities.
• Support or author regulatory documents for authorities (FDA, TÜV).
• Lead sub-projects, coordinate stakeholders, and ensure compliance with guidelines.

Skills

Process design

Project management

Regulatory understanding

Education

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

Tools

Databases

Job description

Roche in Pleasanton, CA seeks a Process Specialist to design, optimize core R&D processes and manage development activities, including requirements, risk, and configuration management. You will support regulatory document creation for authorities and lead sub-projects across units, ensuring compliance and strong stakeholder collaboration.

The role emphasizes process excellence, cross-functional teamwork, and mentoring colleagues while driving future-oriented ways of working within Roche.