Director Of Quality Assurance - Quality Management System
Catalent
Madison, WI, US
Fda and regulatory compliance oversight
Cgmp production and testing management
Deviation and investigation approval
The Director of Quality Assurance is responsible for ensuring compliance with FDA and other regulatory agency requirements while managing site-wide quality systems
Job Summary
The Director of Quality Assurance is responsible for ensuring compliance with FDA and other regulatory agency requirements while managing site-wide quality systems.
This role involves coaching direct reports, overseeing investigations into deviations, and supporting clinical and commercial programs for active pharmaceutical ingredients.
Catalent offers a defined career path, diverse inclusive culture, and generous benefits including medical, dental, vision, and a 401k match effective day one.
Matching Summary
The Director of Quality Assurance is responsible for ensuring compliance with FDA and other regulatory agency requirements while managing site-wide quality systems.
Skills & Requirements
Must-have
FDA and regulatory compliance oversight
CGMP production and testing management
Deviation and investigation approval
Quality systems implementation and maintenance
Internal and external auditing experience
Nice-to-have
Experience with Catalent leadership programs
Ability to communicate complex technical info
Fast-paced entrepreneurial team environment
Strategic planning for regulatory milestones
Key Requirements
Bachelor's degree in STEM with 15+ years experience
Master's degree in STEM with 12+ years experience
PhD with 8+ years experience
Six years of leadership experience required
Commanding understanding of full Biologics process