ProKidney Corp.

Compliance

• Lead validation projects, including the planning, execution, and documentation of computer system validation deliverables.
• Lead qualification, validation, and periodic review activities for laboratory and manufacturing instrument software and systems.
• Ensure continued GxP compliance of QC laboratory computer systems and software.
• Coordinate with IT Operations team to ensure data backup and disaster recovery strategies for critical laboratory systems are setup.
• Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents).
• Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs.
• Review and approve validation deliverables authored by internal teams and external vendors.
• Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems.
• Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment.
• Lead the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies.
• Conduct audits of IT systems, vendors, and validation documentation.
• Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews.
• Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions.
• Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented.
• Perform system risk assessments to determine GxP classification and validation requirements.
• Manage vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments.
• Be onsite to provide vendor oversight, when needed.

Senior Manager – IT Assurance and Compliance