Director Quality Science & Technology
Core
Senior quality executive accountable for portfolio-level quality strategy, regulatory risk governance, and lifecycle readiness for biological drug substances, reagents, and complex chemistry molecules.
Role type
Senior IC Director of Quality Science & Technology
Builds
Biological drug substances, reagents, and complex chemistry molecules for therapeutic applications
Domain
Biopharmaceuticals / Complex Chemistry
Required skills
Quality Risk Management, GMP compliance, lifecycle management, change control, validation strategies, statistical methods, supplier quality, regulatory risk assessment
Preferred skills
Six Sigma, ASQ certifications, leadership in matrixed organizations
Technologies
QMS, GMP systems, risk management tools
Responsibilities
Develop portfolio-level quality strategies and compliance plans; oversee design control and risk management for new products; lead change control and technology transfer assessments; maintain and evolve the Quality Management System; drive continuous improvement using post-market data; build and develop quality engineering teams.
Seniority
Senior, hands-on IC with executive influence