ilb Consulting Services

Consultant

• Lead development of the validation strategy within the first 30 days of onboarding.
• Oversee CSA compliance execution aligned with the customer SDLC and quality procedures.
• Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary).
• Ensure readiness for formal testing and completeness of change control documentation.
• Support CMDB governance and provide guidance on validation and testing tools.
• Monitor KPI adherence including approval cycle time and traceability coverage.

Lead Consultant

Project Manager

• Collect and assemble status reports from the projects
• Document meeting minutes and partner in the preparation of meeting agendas for meetings
• Communicate task and timeline expectations to the project teams
• Document interdependencies as communicated by project managers
• Maintain RAID logs for the projects
• Communicate status and risk/issues appropriately to an executive audience
• Drive follow-up on risks, issues, actions discussed during Program Governance Meetings
• Support collection of KPI metrics to present during Program Governance Meetings
• Facilitate Program Management Office touchpoint meetings

Administrative Project Manager – Pharmacovigilance Consultant

Compliance

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches

Lead Consultant

Administrative Project Manager – Pharmacovigilance Consultant

Computer System Assurance Consultant – PV, Clinical, Regulatory Affairs