Senior Validation Leader — GAMP/GxP, CFR 11

ProKidney Corp.; Winston-Salem (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

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.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering is required.
• Minimum 7 years in biopharmaceutical/related environment with 3+ years in leadership.
• Experience with GxP, CFRs, Annex 11, and data integrity requirements.
• Strong knowledge of GAMP 5 and validation lifecycle.
• Proficiency in writing computer system validation protocols and reports.

Responsibilities

• Provide leadership and direction to Validation team; drive performance.
• Ensure adequate resourcing to meet site objectives; collaborate with Director of Validation.
• Interact with cross-functional leaders on multi-department projects.
• Lead continuous improvement initiatives within the Validation organization.
• Support regulatory inspections (FDA, etc.) and company audits.
• Identify opportunities to improve delivery efficiency and reduce costs.

Skills

Leadership

Cross-functional collaboration

Technical writing

Project management

GxP compliance

Data integrity

Process improvement

Problem solving

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Calibration/maintenance software

Electronic document management systems

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.