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ProKidney Corp.

Senior Validation Leader — GAMP/GxP, CFR 11

winston salem, NC

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About this opportunity

ProKidney Corp. lists this Senior Validation Leader — GAMP/GxP, CFR 11 opportunity in winston salem, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.

Job description

ProKidney is seeking a Sr. Manager of Validation to lead the on-site Validation team, acting as a people leader and hands-on contributor.

You will drive cross-functional alignment and own the full lifecycle of validation documentation per GAMP 5, 21 CFR Part 11, and FDA guidance. Responsibilities include providing direction, ensuring resources, interfacing with QA, Manufacturing, and Engineering, and guiding improvements while supporting regulatory inspections.

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Worksite address

winston salem, NC, 27104, US

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