QRM Lead – Digital Core Implementation
Summary
The QRM Lead is responsible for developing and embedding a modern, risk-based quality management approach within a digitally enabled manufacturing environment. This role ensures quality risk management principles are integrated across operations, systems, and processes while supporting operational resilience and regulatory compliance.
Responsibilities
Design and implement a site-wide Quality Risk Management (QRM) framework aligned with ICH Q9(R1) principles.Embed risk-based thinking across manufacturing processes, digital systems, automation platforms, data flows, and quality oversight activities.Assess and manage risks associated with digital and enterprise systems including DCS, MES, eBR, ERP, data historians, and network infrastructure.Develop and oversee business continuity and contingency strategies to maintain GMP compliance...