Serves as a subject matter expert (SME) for Quality Risk Management and Data Integrity programs.
Facilitates cross-functional teams in the application of Quality Risk Management and Data Integrity principles.
Supports GxP change controls.
Leads formal risk assessments using recognized risk tools.
Authors, reviews, and routes Risk Assessment Reports in MasterControl.
Evaluates residual risk following implementation of mitigation activities.
Coaches SMEs and cross-functional Partners on effective mitigation strategies.
Develops and delivers training on Quality Risk Management tools and methodologies.
Manages multiple risk-related projects independently.

High school diploma or GED
6+ years of experience in a GxP manufacturing, testing, quality, or regulated operational environment
Hands-on experience facilitating formal risk assessments with cross-functional teams
Strong working knowledge of Quality Risk Management principles, tools, and application in a regulated GxP environment.
Experience applying risk tools such as FMEA, risk ranking and filtering, hazard analysis, or other structured risk assessment methodologies.
Solid understanding of FDA, EMA, ICH, USP, and cGMP expectations related to Quality Risk Management, Data Integrity, and pharmaceutical quality systems.
Strong critical thinking, analytical, and problem-solving skills.
Proficiency with MS Office products, especially Word and Excel essential;

Quality Risk Specialist IV

Key skills