Validation Remediation Manager (3 years contract)
Core
Leading the transformation, integration, and execution of validation activities across regulated operations to drive sustainable compliance and inspection-ready execution.
Role type
Senior Validation Remediation Manager
Builds
Integrated, lifecycle-based validation model for regulated operations
Domain
Healthcare (Medical Devices, Nutrition) / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, GMP compliance, Cross-functional leadership, Risk-based decision making, Project management, Inspection readiness, CSV expertise, Consultant management
Preferred skills
Advanced degree, PMP certification, Experience with Warning Letter or consent decree remediation
Technologies
GMP, CSV, MPI
Responsibilities
Lead enterprise or site-level validation transformation initiatives, Drive execution of validation remediation activities across process validation, cleaning validation, equipment and utility qualification, facilities qualification, and computerized system validation (CSV), Partner with Quality Assurance, Engineering, Manufacturing, IT, Supply Chain, and external consultants, Establish and oversee validation governance models, Evaluate Validation deliverables and procedures to prioritize activities and justify compliance decisions, Support regulatory inspections and audits, Manage timelines, milestones, resources, and risks for complex validation initiatives, Drive long-term improvements to validation standards, SOPs, templates, training, and competency models
Seniority
Senior, hands-on IC with strategic oversight
