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 Skillset
• Management (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