Design Quality Partner

Design Quality Partner (DQP)

Roche is seeking a highly motivated Design Quality Partner to join the Product Development Quality organization. This role focuses on enabling project acceleration, ensuring quality and compliance, and fostering a culture of collective success while supporting the development of next-generation AI tools.

Responsibilities

• Partner with stakeholders to ensure milestone readiness and deliverable quality.
• Review and approve project deliverables, acting as a risk enabler in decision-making.
• Manage quality processes including design changes, Non-Conformances, and CAPA.
• Drive standardization and continuous improvement of processes and templates.
• Support internal and external regulatory audits.
• Lead change management and knowledge sharing across R&D and quality functions.
• Provide matrix leadership and mentorship to support team growth.

Requirements

• Bachelor's degree in Engineering, Science, Business Administration, or a related field.
• 3+ years of experience in Quality Management Systems (QMS) and design controls.
• Strong understanding of regulatory requirements such as ISO 13485, FDA, or GMP.
• Interest or experience in AI capabilities and tech-driven compliance.
• Exceptional technical writing, communication, and facilitation skills.
• Willingness to travel internationally as required.