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Sr. Manager of Validation at ProKidney - ApplyBlast

Sr. Manager of Validation

ProKidney

1 month ago

3.9 on Glassdoor

Winston-Salem, North Carolina, United States

Onsite

Full Time

Manager

0 applicants

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About this role

The Sr. Manager of Validation leads ProKidney's on-site Validation team, providing both people leadership and hands‑on technical expertise. This role establishes operational objectives, drives cross‑functional alignment, and oversees the full lifecycle of validation documentation in compliance with GAMP 5, 21 CFR Part 11, and FDA guidance.

Responsibilities

Lead on‑site Validation team and provide technical guidance
Develop and manage full lifecycle validation documentation
Drive cross‑functional alignment and continuous improvement initiatives

Skills

Qualifications

Bachelor's degree

About ProKidney

prokidney.com

Headquarters

Winston-Salem, North Carolina, United States

Company Size

51-200 employees

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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.