Strategic IT GxP & Quality Systems Leader

ProKidney Corp.; Winston-Salem (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

ProKidney is seeking an Associate Director, IT GxP & Quality Systems in Winston-Salem, NC to lead strategic programs within the regulated technology landscape and own the Quality Management Systems environment. You will ensure compliance, inspection readiness, and lifecycle management across GxP platforms.

You will partner with Quality, Clinical, Regulatory, Manufacturing and IT to deliver scalable, compliant technology solutions and drive continuous improvement across the organization.

Qualifications

• 10+ years leading GxP and Quality Systems in regulated life sciences environments.
• Strong hands‑on experience with QMS platforms; MasterControl preferred.
• Experience with GxP platforms for Quality, Regulatory, and Clinical operations.
• Knowledge of CSV/CSA, data integrity, audit trails, and electronic records.

Responsibilities

• Lead GxP and Quality Systems portfolio strategy, governance, and lifecycle management.
• Own the QMS environment, roadmap, validation, integrations, and optimization.
• Drive process harmonization, automation, and continuous improvement initiatives.
• Lead cross‑functional programs with Quality, Clinical, Regulatory, Manufacturing, and IT.
• Manage vendors, partners, and service providers to deliver high‑quality outcomes.

Skills

Stakeholder management

Program management

Leadership

Regulatory knowledge

Quality Systems

GxP compliance

Education

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, IT

Tools

MasterControl

Veeva

LIMS/LabVantage

TrakCel

Job description

ProKidney is seeking an Associate Director, IT GxP & Quality Systems in Winston-Salem, NC to lead strategic programs within the regulated technology landscape and own the Quality Management Systems environment. You will ensure compliance, inspection readiness, and lifecycle management across GxP platforms.

You will partner with Quality, Clinical, Regulatory, Manufacturing and IT to deliver scalable, compliant technology solutions and drive continuous improvement across the organization.