Sr. Director, Quality Operations

ProKidney(1 day ago)

United States, Winston-Salem, NC, North CarolinaOnsiteFull TimeDirector$177,534 - $237,622 (estimated)Quality Assurance

About this role

The Senior Director, Quality Operations leads GMP Quality Assurance for ProKidney’s drug product manufacturing across all sites, ensuring compliant production and material and batch release for clinical and commercial supply. The role is responsible for establishing and maintaining GMP quality systems to support phase III/commercial readiness and regulatory compliance for product commercialization.

View Original Listing

Required Skills

GMP
Quality Assurance
Batch Review
Material Release
Validation
Aseptic Processing
CAPA
Regulatory Compliance
Leadership
Risk Assessment

+1 more

Qualifications

Bachelor's Degree in Scientific or Allied Health Field

About ProKidney

prokidney.com

ProKidney is a late clinical‑stage biotechnology company developing a first‑in‑class cell therapy candidate to treat advanced chronic kidney disease (CKD). Their lead program aims to preserve kidney function in patients who have limited therapeutic options and to transform the therapeutic landscape for progressive CKD. As a pioneer in CKD therapeutics, ProKidney is advancing clinical development to demonstrate safety and efficacy of regenerative approaches. The company focuses on addressing a major unmet need in kidney disease through novel cell‑based treatments.