Quality Site Head
Core
Lead the Quality Management System (QMS) for a manufacturing plant, ensuring regulatory compliance and product safety.
Role type
Senior Quality Site Head (Quality Management Representative)
Builds
Global medical device and healthcare product manufacturing operations
Domain
Medical device / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) leadership, FDA regulations, Good Manufacturing Practices (GMP), regulatory inspection management, quality organization budgeting and staffing, product safety risk management, manufacturing process knowledge
Preferred skills
Advanced degree in Engineering or Science, experience in global organizations
Technologies
QMS software, regulatory compliance tools
Responsibilities
Provide overall leadership and governance for the site QMS; Serve as the site Quality Management Representative; Lead preparations for and management of regulatory inspections and external audits; Establish and monitor measurable quality objectives; Direct the planning, staffing, development, and budgeting of the site quality organization; Ensure effective evaluation and management of product safety risks; Review and approve quality-related procedures and product disposition decisions
Seniority
Senior, hands-on IC with strategic leadership
