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 ensures Quality compliance of product life cycle management, Quality council and oversight of suppliers, third parties, complaints process, documentation management, and periodic product reviews.
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
GxP standards adherence
regulatory requirements compliance
product life cycle management
supplier oversight
documentation management
inspection readiness
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)
Experience applying U.S. Food and Drug Administration (FDA) regulations
Experience applying international regulatory requirements