# Senior Manager, Validation at Prokidney Corp.

- Company: Prokidney Corp.
- What the company does: ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
- Company website: https://prokidney.com
- Type: Startups
- Level: Senior
- Location: Winston-Salem, North Carolina, United States
- Work setup: On-site
- Posted: 2026-09-01
- Apply by: 2026-10-16
- Apply: https://job-boards.greenhouse.io/prokidney/jobs/5225114007
- Page: https://www.1752.vc/careers/jobs/prokidney-corp-senior-manager-validation/

## About the role

The Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation — including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs — in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.

## What they're looking for

- Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering
- A minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with data integrity practices and compliance

Tags: Validation

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/prokidney-corp-senior-manager-validation/