Manager, GxP Systems
Core
Lead validation, qualification, and testing activities for GxP applications and infrastructure across Moderna's Digital landscape using Computer Software Assurance (CSA) principles.
Role type
Manager, GxP Systems Validation & Testing
Builds
Validated and qualified GxP applications, platforms, data solutions, and infrastructure
Domain
Pharmaceutical/Biotechnology / GxP Compliance & Software Assurance
Required skills
GxP computerized systems validation, Computer Software Assurance (CSA), risk-based validation strategies, regulatory requirements knowledge (21 CFR Part 11, EU Annex 11, GAMP 5), validation deliverable authoring, SaaS/cloud GxP applications, SDLC and change management, contractor oversight
Preferred skills
AI/ML validation in GxP environments, automation and digital tools for validation, validation methodology improvement, multi-domain technology validation
Technologies
CSA, 21 CFR Part 11, EU Annex 11, GAMP 5, SaaS, Cloud Infrastructure, AI, Automation
Responsibilities
Partner with Digital, Compliance, and Quality teams to define validation requirements and enable timely delivery; Own and deliver validation, qualification, and testing activities for GxP applications and infrastructure; Develop and execute risk-based validation strategies using CSA principles; Author, review, and approve key validation deliverables including plans, risk assessments, and reports; Lead planning and execution of testing ensuring appropriate assurance levels; Provide technical direction and oversight to contractors and delivery partners; Define and improve processes, methodologies, and tools for validation and qualification
Seniority
Manager, hands-on leadership with team oversight