Manager Quality Risk Management
Core
Lead the implementation of global Quality Risk Management (QRM) governance processes to ensure compliance with regulations at drug substance manufacturing sites.
Role type
Manager, Quality Risk Management
Builds
QRM governance programs and risk management systems for pharmaceutical manufacturing
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
Quality Risk Management (QRM) principles, GxP compliance, risk assessment methodologies, team leadership, recombinant protein manufacturing knowledge, regulatory inspection readiness
Preferred skills
Experience with highly automated manufacturing facilities, cross-functional collaboration
Technologies
QRM software tools, risk assessment frameworks
Responsibilities
Formulate risk management principles and documents, lead data-driven risk assessments, train staff on QRM practices, manage QRM program implementation, represent the company during regulatory inspections, coach and support direct reports
Seniority
Manager, people leadership
