Sr. Director, Quality Operations

Role: Senior Director of Quality Operations overseeing GMP QA for ProKidney's clinical and commercial biologics manufacturing, focusing on aseptic, sterile product production. Responsibilities: provide strategic and operational leadership across Manufacturing, Quality Control, and Warehouse/Distribution to ensure compliance with cGMPs and global regulatory standards (FDA, EMA, ICH); manage batch release, data integrity, investigations, CAPA, and audit readiness; mentor staff and lead cross-functional projects to enhance quality systems; oversee risk assessments and change controls. Requirements: Bachelor's in a scientific or health field, 10+ years sterile manufacturing QA experience, particularly in biologics, cell, or gene therapy; extensive GMP and regulatory knowledge; proven leadership in high-performance QA teams; strong understanding of aseptic processing, cleanroom operations, and regulatory inspections. HighValue: biologics, cell/gene therapy, sterile manufacturing, GMP, IND to commercialization transition, FDA/EMA compliance, investigation and CAPA management. WorkSetup: not specified; likely on-site given manufacturing oversight.