Process and Personnel Qualification Management Expert

Title: PDM PPQME (Process and Personnel Qualification Management Expert)
Duration: 5+ Months

Location:

West Chester, PA
Role can be remote

Essential Job Duties and Responsibilities:
This position reports into Process and Data Management (PDM) within IM Quality Systems. The PDM-PPQME Contractor is responsible for supporting clinical R&D and/or device business process owners in the end-to-end process for procedural document development and compliance training development and deployment in the Quality Management System (QMS) framework.

Responsibilities include:
" Define and manage project plans, tasks, schedules, scope, timelines, and deliverables.
" Perform project management across the life cycle from procedural document development and approval (in EDMS) to training identification, target audience identification, training material development, and training deployment (in LMS).
" Perform quality check of procedural documentation and provide feedback to business partners for consideration.
" Ongoing communication with business owners on project progress and resolution of issues.
" Work with peers in PDM to ensure compliant training and procedural documents are installed for dedicated processes.

Minimum Qualification:
" College Degree Required, minimum of 5 years experience in medium to large organization.
" Strong ability to problem solve and think critically.
" Ability to work collaboratively with a large group of internal and external colleagues and partners.
" Ability to multi-task and manage a large volume of projects
" Strong attention to detail and highly organized, works independently
" Strong written and verbal communications.
" Proficient in MS Office products (Outlook, Word, Excel, PowerPoint)

Other requirements:
The PPQME should have experience working with automated systems, especially Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).