GxP IT Validation Lead

Required

• Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences. Typically seven or more years of relevant experience, with demonstrated delivery capability carrying more weight than a specific tenure threshold.
• Personal ownership of validation engagements, including authoring deliverables, executing or coordinating testing, resolving QA comments, and completing approved validation packages.
• Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+, and risk-based validation and assurance methods.
• Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with an understanding of the supporting IT infrastructure and shared responsibilities.
• Ability to distinguish GxP impact, intended use, and system risk, and translate those judgments into a justified validation approach.
• Experience maintaining validated systems through change control, release assessments, or periodic reviews.
• Experience supporting a QA review, sponsor audit, supplier audit, external audit, or regulatory inspection involving computerized systems or IT controls.
• Strong technical writing, client communication, and organizational skills, with the ability to manage several concurrent assignments.
• US work authorization and residence in the United States.