CSV Lead (Managed Services)

Responsible for managing end-to-end CSV deliverables for both new & existing applications. Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems. Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. Support Engagement Lead with resource interviews, allocation, utilization, schedule forecasting & adjustments as required. Author the following CSV Deliverables: Initial System Assessment, Functional Specifications, Functional Risk Assessment, Design Documents, SOP Planning, Data Integrity Assessment, Traceability Matrix, protocols (IQ, OQ, PQ), Interim Memo & Validation Summary Report QA Review of the following CSV Deliverables: User Requirements, SOPs Application Administrative Tasks & Protocol Deviation Required SkillsetManagement (fte and / or contractors) The must haves! Project Management experience (keywords that our recruiters use for their search) Need to have strong experience in CSV ERP, Lab Systems, Automation, and Manufacturing Personality: Strong Communication skills, internally and externally to our clients' clients Go getter / someone who takes initiative / someone who is proactive