Manager/Sr. Manager, Validation - CSV & Data Integrity
Genezen, Lexington, MA +1
The role
The Manager/Sr. Manager, Validation - CSV & Data Integrity is responsible for ensuring that computerized systems supporting GxP operations are appropriately assessed, validated, implemented, controlled, and maintained throughout their lifecycle. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Supports the Data Integrity program to ensure that GxP data is reliable, complete, accurate, attributable, secure, and maintained in accordance with regulatory expectations and company quality standards.
Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best‑in‑class validation practices that support our Quality Management System and operational excellence.