SAP Validation Project ManagerCalifornia City, CA, United StatesAbout the Job SAP Validation Project ManagerJob Requirements:Coordinate the GxP validation activities amongst the validation and functional/technical team membersPrepare and maintain the project plan for validation function based on overall project planTrack and report the status of the Validation activities against the project planOrganize validation related activities and deliverables in accordance with the project timelines.Make sure individual validation activities are aligned with the strategic direction of the program Develop an evaluation method to assess the validation workstream strengths and identify areas for improvementManage Global project teams with a diverse array of vendors, talents, and responsibilities Engage stakeholders to align validation workstream priorities, coordinate interdependencies, and navigate risksManage changes and intervene as needed to ensure project goals are achievedMeet with stakeholders to make communication easy and transparent regarding project issues and decisions on servicesProduce accurate and timely reporting of validation workstream status throughout the implementation (multiple releases)Analyze program risks and update RAID log accordinglySkills:Project managementExcellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.Knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11Knowledge of computer system validation and GAMP -5 standardsDeliverables:Stakeholders registerRisk & Issues (RAID) LogProgram Communications Management PlanProgram Weekly/Monthly Status reportMeeting Notes I Action Items post every meetingProject Change Request / Change Order if any v111. Go-Live Sign Off/ Final Project AcceptanceLessons Learnt document