New Manager, IT Assurance and Compliance

ProKidney 👨👩👶

Benefits

Job Description

The IT Assurance and Compliance Manager is responsible for ensuring all GxP computerized systems are implemented, validated, and maintained in compliance with applicable regulatory and industry standards, including FDA, ICH, GAMP 5, and global Health Authority requirements. This role leads validation efforts for new software implementations, manages the lifecycle of validated systems, and ensures sustained compliance through continuous monitoring and governance. This role will combine deep technical expertise in computer system validation, a strong understanding of quality systems, and excellent cross-functional collaboration skills to ensure IT systems operate reliably, securely, and compliantly across the enterprise. This includes leading or supporting validation projects, collaborating with QA teams, providing guidance on computerized systems, and reviewing validation deliverables.

About ProKidney

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, etc.

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