Director, GCP Inspection Readiness and Audits Strategy
Core
Lead Kardigan's approach to inspection readiness and risk-based audit program in the GCP space to ensure organizational readiness for regulatory inspections.
Role type
Director, GCP Inspection Readiness and Audits Strategy
Builds
Regulatory inspection readiness frameworks and risk-based audit strategies for a cardiovascular drug development company
Domain
Biotechnology / Clinical Trials / GCP Compliance
Deliverable
client delivery
Required skills
GCP inspection readiness, FDA BIMO context, clinical development compliance, sponsor oversight, CRO/vendor oversight, IRB/ethics committee interactions, data integrity, risk-based thinking, strategic orchestration
Preferred skills
Medical devices experience in clinical trials
Technologies
None stated
Responsibilities
Establish a framework for continuous inspection readiness; Partner with Clinical Quality Leads to embed readiness into program execution; Lead cross-functional alignment on holistic inspection risks; Define and implement tools and training for inspection readiness; Oversee readiness exercises and mock inspections; Develop and maintain a risk-based annual audit plan; Monitor regulatory trends and enforcement actions; Establish a pool of external auditors
Seniority
Director, strategic leadership
