Strategic Quality Partner — NGS Diagnostics, Onsite

Roche; Santa Clara (CA); On-site; USD 119,400 - 255,380; Full time

Job summary

Roche in Santa Clara, CA seeks a Strategic Quality Partner to drive development quality for the Molecular Lab - Sequencing Solutions portfolio. This onsite role focuses on aligning global requirements with project teams, deploying Design & Development processes, and enabling risk-based decision making to accelerate milestones.

You will lead cross-functional collaboration, support audits, and ensure timely feedback loops into development.

Qualifications

• Bachelor's degree in science, engineering, business or related field.
• MBA or advanced degree is an advantage.
• 8+ years of experience in the diagnostics industry or related field.

Responsibilities

• Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs).
• Incorporate lessons learned from quality across CA into project support and PostMarket Quality feedback.
• Ensure development project plans deliver the Design & Development module deliverables for safe, compliant solutions.
• Support internal and external audits.
• Lead and facilitate discussions at project team meetings.
• Drive risk-based decision making and enable timely decisions.

Skills

NGS knowledge

Regulatory knowledge

Leadership

Agile knowledge

Communication skills

Education

Bachelor's degree

MBA

Job description

Roche in Santa Clara, CA seeks a Strategic Quality Partner to drive development quality for the Molecular Lab - Sequencing Solutions portfolio. This onsite role focuses on aligning global requirements with project teams, deploying Design & Development processes, and enabling risk-based decision making to accelerate milestones.

You will lead cross-functional collaboration, support audits, and ensure timely feedback loops into development.