Procedural Document Facilitator/Quality Management System Specialist IV

Posted Jan 23, 2020
Project ID: SHPGJP00004758
Lexington , MA
9 months
(Feb 3, 2020 - Nov 2, 2020)
40 hrs/week
Payrate range
*********Maximum Bill rate is$90 to $120/hour inclusive**********

New Title: R&D Process Lifecycle Management and Support Lead

The Shire Consultant Procedural Document Facilitator/Quality Management System Specialist will be responsible for leading and executing activities related to procedural document development and training within R&D QA & Compliance, R&D as a whole, with touch points across Shire. This holistic view of the procedural document life cycle includes but is not limited to: quality facilitation of procedural document workgroups, harmonization of document subject areas where appropriate, authoring, reviewing, editing, appropriate documentation and archival of superseded material, and quality control of documents, reviewing regulatory requirements, identification and assignment of training in Shire’s Learning Management System, and training development and implementation.

Under the direction of the head of the Quality Management System Standards, the person assuming this role will be expected to lead cross functional teams of Process Owners, Content Experts and functional area Subject Matter Experts, through an R&D document harmonization and biennial review process that is critical to Shire meeting regulatory requirements and compliance commitments.

The Procedural Document Facilitator is required to be an expert user of the Controlled Document Management System (CDMS) and will lead work flow facilitation of procedural documents within Shire’s CDMS.

The Consultant Procedural Document Facilitator/Quality Management System must have at least 10 years of procedural document development experience, have proven Project Management/Project Facilitation experience as well as exceptional interpersonal skills and attention to detail to lead content experts through the development of multiple procedural documents simultaneously. Also required is an understanding of the Quality Management System and the integral role

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