Director, Corporate Quality - GCP
Core
Provide leadership and strategic quality oversight for Clinical Development and Real-World Evidence portfolios, ensuring GCP/GLP compliance and patient safety.
Role type
Director, Corporate Quality (GCP/GLP)
Builds
End-to-end regulatory compliance, scientific integrity, and patient safety for clinical and non-clinical studies.
Domain
Biopharmaceuticals / Clinical Development / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP compliance, GLP compliance, audit management, CAPA development, regulatory submission review, inspection readiness, Quality Management Systems (QMS), ICH guidelines, FDA regulations, EU requirements
Preferred skills
Non-clinical Quality Assurance experience, Regulatory Authority Inspection support, Advanced degree (Master's/PhD)
Technologies
GxP-compliant procedures, audit planning tools, regulatory submission platforms
Responsibilities
Provide leadership on GCP and GLP QA support and guidance to stakeholders; Act as primary Quality business partner to R&D functional leaders; Partner with teams to resolve compliance issues at vendors and investigator sites; Assist in developing and implementing CAPA plans; Review clinical trial documentation and regulatory submission materials; Develop and maintain study-specific audit plans; Support inspection readiness activities; Contribute to continuous improvement of GxP-compliant procedures.
Seniority
Director, strategic oversight & cross-functional leadership
