Design Quality Partner

About the role

Roche is looking for a Design Quality Partner (DQP) to join its Product Development Quality organization. The role is a key enabler of project acceleration, balancing workload across customer areas through flexible allocation and building effective partnerships within Quality and Regulation. It sits alongside a team developing a next-generation AI tool.

Key responsibilities

• Partner with Strategic Quality Partners and cross-functional stakeholders to ensure milestone deliverables are complete and appropriate
• Review and approve milestone deliverables in development projects and act as a risk enabler in decisions
• Ensure timely execution and quality process management for design change requests, non-conformances and CAPA
• Reduce complexity and drive standardization of templates, review processes and content across projects
• Support internal and external regulatory audits
• Embed and improve knowledge sharing and retention within Pre-Market Quality
• Lead change management across Product Development Quality, R&D and related functions
• Provide matrix leadership for global project teams and coach colleagues, especially junior team members

Required profile

• 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 quality and regulatory requirements for reviewing Design History File (DHF) content (e.g. ISO 13485, FDA, GMP)
• Solid understanding or curiosity about AI capabilities and models
• Willingness to travel internationally depending on business needs

Required skills

• Exceptional technical writing
• Data interpretation
• Communication, collaboration and facilitation
• Ability to focus on the right degree of detail