Example Experience: Minimum of six (6) years of experience as a Program or Project Manager within the following fields: Life Sciences, Research & Development, Clinical, and Information Technology. Bachelors or Masters level of education in a Life Science, Business or Project Management discipline or related field, or equivalent experience preferred. Prefer at least five years of direct project management experience within the medical device or pharmaceutical industries coordinating and organizing projects and teams.
Point person responsible for daily hands-on management of assignments throughout the lifecycle of an assigned project including the project team. Responsible for managing large and complex projects (in conjunction with Project Lead and/or Consulting Director) with single or multiple work-streams, or managing internal and external audit programs.
Assist with the development of project plans, tracking and process monitoring activities, which include the development of the necessary project tools and documents. Create and maintain schedules, workflow, and documents, as well as communication within the consulting team. Plan, track and align deliverables to the scope of the project.
Perform quality assurance oversight for outcomes and personnel involved in the project. Report on output and outcomes (i.e. KPIs/metrics). Proven experience with project management computer tools and software to map out project plans, update project status, and communicate with project team. Experience in document control. Must have the ability and willingness to travel.
Technical Experience: Experience in at least one of the following areas: Quality Systems, Complaint Handling and Post Market Reporting, Production & Process Controls (including Process Validation), Test Method Validation, Design Controls, Risk Management, CAPA, Computer System Validation, Purchasing & Supplier Controls, Document Controls, Management Controls, Recalls, Training, Process Engineering, and New Product Development.