Associate Manager Document Control

Within this role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the following : document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics.

As an Associate Manager Document Control, a typical day might include, but is not limited to, the following :

Managing direct reports (e.g. coordinators, Archivist, etc.) that may also have direct reports

Establishing and communicating group and individual goals for group in accordance with department goals

Partnering with counterparts from sister sites to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements

Ensuring timely prioritization of work and projects and adequate resource availability

Reporting status of process performance and providing monthly metrics for presentation; includes Quality Operations systems metrics

Acting as the voice of Doc Control and the Archives for the Raheen site in manager’s meetings and other cross-functional communications

Providing coaching and guidance to employees for performance and development

Assisting in administration of the controlled document management system and recording tracking system to ensure optimization as needed

Site leading for Doc Control global teams, projects, and initiatives; continuously partnering with counterpart site leads

Interfacing directly with regulatory or partner inspectors, as needed, to represent documentation system and document archival

Providing advice to user departments on format, style, and architecture of documents to enhance standardization and clarity, and to minimize unnecessary changes

Training departmental staff in procedures and cGXPs, as well as training user departments in the documentation systems as needed

Monitoring expenses based on departmental budget

Supporting manager with data and analysis of resources and activities to allow for accurate headcount and workload forecasting for the Doc Control and Archives areas

Leading organizational design and Doc Control / Vault infrastructure requirements ensuring the optimal design of the team and operations

Supporting global communication and visibility with manager through practices such as huddles and the Tier Board

Triggering communication with areas to gather feedback to use to improve processes allowing the business to understand our processes and improve overall efficiency and effectives of our systems

To be considered for this opportunity you should have BA / BS in Science, Engineering, Technology & 8 + years of experience.

You should have relevant experience in a cGMP environment. Previous people management and / or team leadership experience required.

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