Senior Manager, Validation

Position Summary

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.

Responsibilities

• Provide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals
• Ensure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation
• Regularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership
• Actively contribute to and continuously improve the culture of the Validation team and the broader site
• Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of V