Senior QMS Operations Leader

Ardelyx is seeking an Associate Director, QMS Operations to lead Deviations, CAPA, Complaints and Change Control with governance and continuous improvement across the QMS. The role partners with Quality, Manufacturing, Regulatory and Supply Chain to drive risk-based processes and a strong quality culture.

The position supports regulatory inspections, internal audits, and process harmonization, while advancing electronic QMS tools and data-driven decision making in a hybrid Waltham environment.