Change Control Author

Found in: Resume Library US A2 - 6 days ago


Worcester Massachusetts, United States AbbVie Full time
Job Description

Purpose

The Change Control Author is the primary point of contact to provide change control execution for drugs, biologics, and medical devices. This role works across multiple functions to bring the appropriate individuals together to build robust change strategies that will be documented in the Change Management IT system (TrackWise).

Responsibilities

Serve as Change Contropl Author for Local Change Plans or Global Change Plans for mature products within a franchise

Work with Requestors of change to ensure Change Proposals are ready for review

Facilitate Cross Functional Team meetings with individuals across multiple geographies

Document Change Plans in SolTRAQs Change Management system

Facilitate Change Review Board meetings to review and approve Change Plans

Progress Change Plans through the SolTRAQs workflow

Monitor open Change Plans/Tasks and provide visibility to Requestors and the Change Review Boards

Accountable for the compliance of the Change Plan documentation to the applicable processes and procedures


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