Senior GxP IT & Quality Systems Leader

ProKidney; Fort Worth (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney is seeking an Associate Director, IT GxP & Quality Systems to lead strategic programs across the regulated technology landscape, owning the QMS environment and ensuring compliance, validation, and lifecycle management of GxP platforms.

You will drive cross-functional initiatives with Quality, Clinical, Regulatory, Manufacturing, and IT, manage external partners, and advance scalability to support commercialization while maintaining inspection readiness.

Qualifications

• Experience leading GxP IT systems in regulated life sciences.
• Strong knowledge of CSV/CSA, data integrity, electronic records and audit trails.
• Ability to manage vendors and cross-functional teams to deliver compliant solutions.

Responsibilities

• Lead Enterprise GxP and Quality Systems portfolio, including strategy, governance and lifecycle management.
• Own the QMS environment, roadmap execution and ongoing optimization.
• Drive process harmonization, automation and continuous improvement of Quality Systems.

Skills

Stakeholder management

Program management

Communication

Leadership

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, IT, or related field

Tools

MasterControl

Veeva

LabVantage LIMS

Job description

ProKidney is seeking an Associate Director, IT GxP & Quality Systems to lead strategic programs across the regulated technology landscape, owning the QMS environment and ensuring compliance, validation, and lifecycle management of GxP platforms.

You will drive cross-functional initiatives with Quality, Clinical, Regulatory, Manufacturing, and IT, manage external partners, and advance scalability to support commercialization while maintaining inspection readiness.