Director, Validation

Responsibilities: Validation Program Leadership Develop and execute the strategic roadmap for laboratory validation supporting transition from clinical-stage development through BLA submission and commercial launch. Establish governance for laboratory validation activities across R&D organizations. Develop policies, procedures, standards, templates, and lifecycle management processes for validation activities. Build a scalable validation framework consistent with current regulatory expectations for computerized systems and laboratory equipment. Lead continuous improvement initiatives to enhance validation efficiency while maintaining regulatory compliance. Equipment and Instrument Qualification Direct qualification activities for laboratory equipment and instrumentation, including: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Requalification Decommissioning Ensure qualification documentation is scientifically justified and risk-based. Define validation strategies based on intended use, product impact, patient safety, and data integrity risk. Computerized Systems Validation (CSV) Lead validation of laboratory computerized systems including: Laboratory Information Management Systems (LIMS) Electronic Lab Notebooks (ELN) Instrument software Scientific applications Laboratory data acquisition systems Ensure systems comply with: 21 CFR Part 11 Annex 11 ALCOA+ data integrity principles GAMP 5 guidance Partner with Information Technology and system owners to manage system lifecycle, upgrades, patches, and periodic review. Inspection Readiness Develop inspection-ready validation documentation supporting FDA pre-license inspections and regulatory audits. Ensure validation packages are complete, traceable, scientifically defensible, and readily retrievable. Lead inspection readiness activities related to laboratory validation. Support regulatory inspections by serving as subject matter expert for: Equipment qualification Computerized systems validation Data integrity Validation lifecycle management Lead remediation activities arising from inspections or internal audits. Quality Systems Ensure validation activities integrate effectively within the Quality Management System. Review and approve: Validation Plans User Requirements Specifications Risk Assessments Functional Specifications IQ/OQ/PQ Protocols Summary Reports Traceability Matrices Periodic Reviews Support change control assessments for validated systems. Ensure deviations are appropriately investigated and resolved. Monitor validation metrics and report program status to senior leadership. Cross-Functional Leadership Partner closely with: Quality Assurance / Quality Control Analytical Development Process Development Translational Medicine Manufacturing Sciences and Technology Information Technology External Contract Laboratories Provide validation expertise during laboratory expansion, technology transfers, implementation of new analytical platforms, and adoption of automation technologies. Evaluate validation impact of new laboratory technologies and digital transformation initiatives. Vendor Management Oversee validation deliverables from equipment manufacturers, software suppliers, and validation consultants. Review vendor qualification documentation. Ensure vendor documentation meets company quality standards and regulatory expectations. Manage external validation resources as needed. People Leadership Build, mentor, and develop a high-performing validation organization. Establish goals, performance expectations, and professional development plans. Foster a culture emphasizing quality, scientific rigor, collaboration, and continuous improvement. Qualifications: