On-Site Validation Leader | GxP and Data Integrity

Scorpion Therapeutics; Winston-Salem (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

ProKidney seeks a Senior Manager of Validation to lead the on-site Validation team and provide technical leadership in GxP-compliant activities. You will set operational goals and drive continuous improvement while ensuring adherence to GAMP 5, 21 CFR Part 11, and FDA guidance.

You will partner with QA, Manufacturing, and Engineering, lead investigations, and support regulatory inspections with hands-on troubleshooting and a strong emphasis on data integrity and GMP 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.

Responsibilities

• Lead on-site Validation team and set operational goals, ensuring compliance with GAMP 5, 21 CFR Part 11, and FDA guidance.
• Collaborate cross-functionally with QA, Manufacturing, and Engineering; support regulatory inspections.
• Hands-on troubleshooting and driving continuous improvement projects to enhance validation processes.
• Promote a culture of quality and compliance across the validation lifecycle.

Skills

Leadership

Validation lifecycle

GxP knowledge

Regulatory compliance

Data integrity

Calibration software

Electronic document management

GAMP

CFRs

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Calibration software

EDMS / Electronic Document Management System

Job description

ProKidney seeks a Senior Manager of Validation to lead the on-site Validation team and provide technical leadership in GxP-compliant activities. You will set operational goals and drive continuous improvement while ensuring adherence to GAMP 5, 21 CFR Part 11, and FDA guidance.

You will partner with QA, Manufacturing, and Engineering, lead investigations, and support regulatory inspections with hands-on troubleshooting and a strong emphasis on data integrity and GMP compliance.