Director Of Quality Assurance - Quality Management System
Catalent Biologics
Madison, WI, US
Not specified; not specified; generous 401k match ...
Fda and regulatory agency compliance
Cgmp production and testing oversight
Deviation and investigation management
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 collaborating with project management to support CGMP programs.
Catalent offers a defined career path, diverse inclusive culture, and comprehensive benefits including medical, dental, and vision 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.
Salary
Not specified; Not specified; Generous 401k match and paid time off accrual
Skills & Requirements
Must-have
FDA and regulatory agency compliance
CGMP production and testing oversight
Deviation and investigation management
15+ years relevant experience in STEM
Leadership of quality assurance functions
Nice-to-have
Experience with Catalent leadership programs
Ability to communicate complex technical info
Fast-paced entrepreneurial team environment
Strategic planning for drug lifecycle support
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