McKesson seeks an Enterprise Quality Validation Engineer for the Enterprise Quality Management function, reporting to the Sr. Director, Enterprise QMS and Quality Engineering. This new function provides validation support for a wide variety of businesses within the McKesson enterprise.

The Enterprise Quality Validation Engineer will ensure software systems used in regulated environments comply with FDA requirements and other applicable guidance, including data integrity and 21 CFR Part 11.

Scope of Responsibilities

• Plans, executes, and documents validation/qualification activities to ensure software systems are fit for their intended use, maintaining data integrity, reliability, and compliance.
• Drafts and executes validation plans, protocols, and reports. Develops and executes software validation protocols (IQ, OQ, PQ) in accordance with risk levels, FDA expectations, and industry standards.
• Creates and ...