Senior Manager, Validation

Role: Senior Manager of Validation at ProKidney, leading the on-site Validation team and serving as both a people leader and technical expert. Objectives include establishing operational goals, ensuring compliance with GAMP 5, 21 CFR Part 11, and FDA guidance, and streamlining validation processes. Responsibilities encompass team leadership and development, resource management, cross-functional collaboration with QA, Manufacturing, and Engineering, and supporting regulatory inspections. The role involves hands-on troubleshooting, driving continuous improvement projects, and promoting a culture of quality and compliance. Qualifications: Bachelor’s degree in Life Sciences or Engineering; 7+ years in biopharma or related environment with at least 3 years in a leadership role; expert knowledge of GxPs, GAMP, CFRs, data integrity, and validation lifecycle; experience with calibration software, electronic document management, and GMP regulations. Preferred skills include familiarity with laboratory systems, automation controls, and cGMP investigation tools. High-Value: emphasis on computer system validation, data integrity, and regulatory compliance within biopharmaceutical validation frameworks. Reporting and stakeholder collaboration are integral to the role. Work setup: on-site at ProKidney; no specific travel requirements indicated.