QMS Process Engineer — Data-Driven Quality & AI

Roche; Welwyn; On-site; GBP 56,000 - 74,000; Full time

Benefits offered by this job

Relocation benefits not available

Job summary

Roche seeks a QMS Process Engineer to deliver operational excellence across CtQ ecosystems, bridging data and quality insights. You will design data-execution workflows, embed GxP standards, and collaborate across functions to prepare for inspections while continuously improving processes with digital tools and AI capabilities.

You will bring 5+ years in regulated environments, strong communication, and a data-driven mindset to drive CtQ improvements in a global setting.

Qualifications

• Bachelor’s degree or equivalent in a scientific or quality-related discipline with 5+ years in a regulated GxP environment.
• Experience in end-to-end product development and operationalization (GCP, GVP, IVD/MD).
• Lean Six Sigma certification preferred; strong data literacy and storytelling.
• Excellent communication, presentation, and stakeholder influence skills.

Responsibilities

• Design, implement, and optimize data-execution workflows and processes.
• Connect AI and automation tools to streamline workflows and enhance system capabilities.
• Translate raw data into actionable quality insights and trend analyses.
• Maintain awareness of GxP regulations and embed CtQ principles in process design.
• Support inspection readiness and monitor performance indicators for data accuracy.
• Collaborate with cross-functional teams to guide QMS updates and provide guidance.

Skills

GxP knowledge

Data analytics

Process improvement

Lean Six Sigma

Quality data storytelling

Regulatory communication

Education

Bachelor's degree or equivalent in a scientific or quality-related discipline

Tools

QMS software

AI tooling

Job description

Roche seeks a QMS Process Engineer to deliver operational excellence across CtQ ecosystems, bridging data and quality insights. You will design data-execution workflows, embed GxP standards, and collaborate across functions to prepare for inspections while continuously improving processes with digital tools and AI capabilities.

You will bring 5+ years in regulated environments, strong communication, and a data-driven mindset to drive CtQ improvements in a global setting.