Title: Project Manager, Sterility AssuranceSummary of Role:This position will support the Sterility Assurance R&D organization by coordinating activities related to separation and R&D footprint activities. Including, but not limited to, setting up project management tools, leading meetings, and tracking work activities, as described in the Description of Role section.Description of Role:Project management key activities related to the setup of the Sterility Assurance team for success as part of a new company.Coordinate the plans, meetings, updates and closure of activities related to both separation and site relocations for footprint activities.Develop tools that enable Sterility Assurance to work through separation and support the new company after separation. Examples include a tool to facilitate resource and testing support needed by other teams within the company.Coordinate project to facilitate learning sessions and a community of practice within the company.Provide regular updates to Sterility Assurance management.Responsibilities include:Coordinate Sterility Assurance planning and execution of activities for separation and R&D footprint changes, including but not limited to knowledge transfer and setup of contract testing lab services. And report this information out to management and the Sterility Assurance team.Coordinate activities with other functions outside of Sterility Assurance.Developing online tools for other functions to request Sterility Assurance 1) resources for support of projects and 2) sample sterilization processingCoordinate activities in support of the Sterility Assurance in depth “Residency” TrainingQualifications. The preferred candidate will have:Experience in project managementExperience in software tools, such as SharePoint and Power BIAbility to effectively coordinate in cross-functional teams with limited guidance.Strong organizational skillsStrong communication skillsDesirable SkillsKnowledge of GDP/GMP/GLP practices.Pharmaceutical or Medical Device knowledge is desirable.Degree in management, engineering, or science related field.B.S. with greater than 4 years of related experience.Projects to Manage:My priorities for this position:Assure progress on challenging Evergreen/Bloom activities, such as KT, BIs, and cycle requestsAssist me in providing updates to ManagementDevelop new resource request toolSupport you in your project management needsResidency TrainingRefresh the Rationale / Impact Assessment processCoP coordinationNote :ShiftUSA-1VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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