Process Lead – Risk Management
by Julphar in Pharmaceuticals
The Process Lead – Risk Management at Julphar is responsible for establishing, implementing, and continuously improving a robust risk management framework aligned with ICH Q9, GMP requirements, and internal company policies. The role ensures risk-based thinking is embedded across all Quality Management System (QMS) processes and supports regulatory compliance, operational excellence, and strategic business objectives. Responsibilities include developing and maintaining risk management frameworks, leading formal risk assessments such as FMEA and Fault Tree Analysis, promoting risk-based thinking across CAPA, change control, audits, deviations, and validation activities, tracking and monitoring risk mitigation plans, leading periodic risk reviews, defining and reporting on KRIs and KPIs, providing training and guidance on risk management methodologies, overseeing lifecycle compliance of QMS components, streamlining quality processes, enabling cross-functional risk-based decision-making, harmonizing local risk management processes with global standards, and ensuring adherence to company standards, GMP, FDA regulations, and international quality requirements. The role requires expertise in risk management methodologies, QMS frameworks, GMP, regulatory requirements, audit processes, quality improvement tools, and continuous improvement methodologies, with strong analytical, documentation, and Microsoft Office skills.