The Quality Compliance Lead is responsible for leading and managing the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies
Job Summary
The Quality Compliance Lead is responsible for leading and managing the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies.
The role drives proactive compliance strategies and continuous improvement initiatives to ensure inspections readiness including PAIs.
The Quality Compliance Lead reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).
Matching Summary
The Quality Compliance Lead is responsible for leading and managing the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies.
Skills & Requirements
Must-have
regulatory inspections and audits
cGMP and GLP compliance
supplier quality management
product life cycle management
quality risk management
continuous improvement initiatives
Nice-to-have
agile and culturally adaptable approaches
driving change management
analytical problem-solving
building collaboration and teamwork
Key Requirements
Bachelor’s degree in physical sciences, Biology, chemistry, pharmaceutical sciences or a related discipline
Experience working in a commercial pharmaceutical manufacturing facility
Experience in Product Lifecycle compliance Management activities
Experience in performing Quality compliance activities
Experience applying current Good Manufacturing Practice (cGMP), U.S. Food and Drug Administration (FDA) regulations, and international regulatory requirements