Quality Systems Document Analyst

Description

Overview:

• This role will assist in managing the procedural documents lifecycle (i.e., policies, standard operating procedures, work instructions, manual, guidelines, and forms) for the Scientific Affairs (SA), US Medical Affairs (MA) and Regional Commercial Quality North America organization in the Electronic Document Management System (EDMS), truVault (Veeva Quality Docs).
• This position is also responsible for ensuring that SA/MA procedural documents are consistent and aligned with Client global processes, including but not limited to Client Enterprise Quality Standards, Cross Sector Documents, Commercial Quality Documents, Client  Guidance Documents, HCC, Cross-Pharma, and Global Medical Organization documents.

The role will assist in the following tasks:

• coordination and tracking of periodic reviews
• revision and obsolescence of documents
• impact assessment process management
• contribution of training contents and audience identification for procedural documents
• updates to the US CQ Quality Manual and related reference documents

Essential Functions:

Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME

Procedural Document Management

• Manage the review & approval cycle to ensure procedural documents meet established development timelines and facilitates periodic review per procedural lifecycle requirements.
• Liaise with other Client organizations when SA/MA or NA CQ procedural documents have interdependencies with those groups.
• Ensures alignment of Client standards, policies and procedures across SA/MA and NA Regional procedural documents.
• Manages procedural documents in electronic document management system
• Reviews findings, and monitors compliance trends related to procedural documents and communicates compliance issues/concerns to department manager.
• Assists during the impact assessment review and documentation process 75%

Training/Compliance

• Assists in identification of procedural document training audience with functional area managers
• Collaborates with Process Owners, Subject Matter Experts, and Training Managers in the development and review of training content/materials.
• Develop procedural document metrics and monitor compliance. 25%