Team Leader, Quality Assurance
Core
Lead the Quality Assurance team and oversee quality functions for clinical packaging operations, ensuring compliance with GMP and FDA regulations for pharmaceutical products.
Role type
Senior IC Quality Assurance Team Leader
Builds
Clinical packaging operations and quality compliance systems
Domain
Pharmaceutical manufacturing / Clinical supply chain
Required skills
cGMP knowledge, FDA regulations, ICH guidelines, risk assessment, root cause analysis, leadership, technical writing, problem solving
Preferred skills
Bachelor's degree in technical or life sciences, experience in leadership roles
Technologies
GMP systems, FDA regulatory frameworks
Responsibilities
Oversee quality team and functions for clinical packaging, ensure site adherence to quality systems, resolve issues and implement corrective actions, interact with clients on quality issues, author and revise procedures, escalate compliance issues, conduct safe and effective activities
Seniority
Senior, hands-on IC