Senior Manager, Validation

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

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:

Responsibility 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:

Preferred skills include familiarity with laboratory systems, automation controls, and cGMP investigation tools.

High-Value:

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.