QA Specialist V-Quality Risk Management
Core
Lead cross-functional quality risk assessments and maintain the site's Quality Risk Management framework to support risk-based decision-making and regulatory compliance in a GMP-regulated environment.
Role type
Senior Quality Risk Management Specialist
Builds
Site-wide quality and risk management strategies and governance processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Risk Management principles, risk assessment methodologies, GMP environment experience, analytical problem-solving, regulatory compliance knowledge
Preferred skills
Cross-functional collaboration, training program development, audit support, continuous improvement
Technologies
Risk registers, governance tools
Responsibilities
Lead cross-functional quality risk assessments, maintain and improve site risk registers, develop and deliver QRM training programs, support audits and inspections, review risk assessments for compliance, drive continuous improvement of the QRM program
Seniority
Senior, hands-on IC
