Description
The Quality Operations Manager supports and implements quality management systems for clinical research, including study document review, quality metrics, sponsor and internal audits, clinical site and vendor audits, FDA inspection readiness, regulatory guidance tracking, SOP and training development, and quality issue resolution. The role may provide training or managerial oversight to a Quality Operations Associate and requires a bachelor’s degree, preferably in a scientific or healthcare field, plus 5–7 years of related experience and knowledge of FDA regulatory requirements.
