Director GCP/GVP Inspection Readiness and Management
Core
Provide strategic leadership for global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs, overseeing inspection readiness and managing regulatory inspections.
Role type
Director, GCP/GVP Inspection Readiness and Management
Builds
Sustainable compliance, operational excellence, and successful outcomes for global regulatory inspections and audits.
Domain
Regulated pharmaceutical and biotechnology industry (Clinical Operations, Pharmacovigilance, Regulatory Affairs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, risk-based audit program management, regulatory inspection hosting, cross-functional stakeholder alignment, compliance risk mitigation, global GCP/GVP regulatory expertise, inspection readiness strategy, CAPA leadership, KPI and trend analysis
Preferred skills
Experience with multiple health authorities (FDA, EMA, PMDA, MHRA), CRO and vendor management, emerging inspection trend analysis
Technologies
GCP, GVP, ICH guidelines, 21 CFR Part 11, ALCOA+ principles
Responsibilities
Lead the development and continuous improvement of the global GCP/GVP Inspection Readiness Program; Serve as primary Inspection Lead and Host for FDA, EMA, PMDA, MHRA, and other Health Authority inspections; Establish inspection readiness strategies for CROs, investigator sites, and external partners; Lead cross-functional development of responses to observations, findings, and CAPAs; Develop and communicate inspection readiness dashboards, KPIs, and risk metrics; Lead a risk-based internal audit program to assess compliance and drive quality improvement.
Seniority
Director, strategic leadership with hands-on program execution
