The Sr. Quality Risk Manager (QRM) is key to driving successful project implementation of a Risk-Based Quality Management (RBQM) strategy. The Sr. QRM will work with the project team to lead and facilitate project risk assessments, develop and maintain the Integrated Quality Risk Management Plan (IQRMP), facilitate strategic quality review meetings, and perform ongoing centralized monitoring reviews. The Sr. QRM will provide mentoring, training and oversight to junior level QRM staff. Additionally, the Sr. QRM will identify, revise, and implement changes to the overall RBQM process as needed.
The QRM is responsible for ensuring project teams develop an integrated quality risk management strategy in compliance with ICH E6R2 guidelines.