$164,838 - $199,745; not specified; health coverag...
Fully remote
Gxp quality systems implementation
Deviations and investigations oversight
Corrective and preventive actions
The Associate Director, Quality Systems is responsible for operational oversight and maintenance of the Indianapolis site Quality Management System for RayzeBio, including establishment, continuous improvement, and ensuring consistent implementation of global quality system policies in the GMP spectrum
Job Summary
The Associate Director, Quality Systems is responsible for operational oversight and maintenance of the Indianapolis site Quality Management System for RayzeBio, including establishment, continuous improvement, and ensuring consistent implementation of global quality system policies in the GMP spectrum.
Key responsibilities include leading/supporting implementation of GxP Quality Systems, overseeing Quality Assurance Systems (Deviations, CAPA, Complaints, Change Control, Document Control, Training), and ensuring site readiness for audits and inspections.
The role requires a bachelor's degree in a science-related field, 7-10 years in GxP environments, and highly desirable 5 years of Quality Systems experience, with knowledge of US, EU, and rest-of-world cGMP regulations.
Matching Summary
The Associate Director, Quality Systems is responsible for operational oversight and maintenance of the Indianapolis site Quality Management System for RayzeBio, including establishment, continuous improvement, and ensuring consistent implementation of global quality system policies in the GMP spectrum.
Salary
$164,838 - $199,745; Not specified; Health Coverage, Wellbeing Support, Financial Well-being, Work-life benefits
Skills & Requirements
Must-have
GxP Quality Systems implementation
Deviations and Investigations oversight
Corrective and Preventive Actions
Change Control and Document Control
Audit and Inspection readiness
Nice-to-have
Transformative radiopharmaceutical therapies
Nimble, pioneering spirit
Multidisciplinary team collaboration
Continuous improvement of QMS
Key Requirements
Bachelor's degree in engineering or life/physical science
7-10 years in GxP pharmaceutical environment
Minimum 5 years Quality Systems experience
Knowledge of US, EU, rest-of-world cGMP regulations