About the role

Quality Management System Process Engineer improving Roche’s regulated pharma data and quality processes. Designing automated workflows, analyzing quality trends, and supporting inspection readiness.

Responsibilities

Partner with the business to design, implement, and optimize data-execution workflows and processes
Connect AI and automation tools to streamline linear workflows and maximize system capabilities
Digest raw data into structured information and conduct trend analyses to identify patterns and systemic findings
Maintain up-to-date awareness of GxP regulations, especially GVP, and embed CtQ principles into process design
Support inspection preparation activities and monitor performance indicators to maintain process and data accuracy
Collaborate with cross-functional teams to guide compliance updates, influence QMS decisions, and offer guidance to peers
Apply expertise to deliver operational excellence across Critical-to-Quality ecosystems
Sustain a robust Quality Management System and support inspection readiness

A Bachelor’s degree or equivalent in a scientific or quality-related discipline (or equivalent practical experience) with at least 5 years of experience
Professional experience in a regulated GxP environment
Solid knowledge of end-to-end product development and operationalization (GCP, GVP, IVD/MD)
Strong understanding of process improvement methodologies (e.g., Lean or Agile)
Lean Six Sigma certification preferred
High digital and data literacy
Proven experience in data analytics and using “quality data storytelling” to solve complex problems
Outstanding communication, presentation, and negotiation skills
Ability to influence stakeholders with or without authority
Demonstrated capacity for critical thinking, independent problem-solving, and navigating ambiguity
Digital and AI acumen in Safety environment preferred