Head of Patient-Facing Quality Assurance
Core
Lead an integrated Quality Assurance organization covering Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) to ensure participant safety, data integrity, and regulatory compliance across clinical trials and post-market monitoring.
Role type
Senior leadership IC (Head of Patient-Facing Quality Assurance)
Builds
Global quality systems, inspection readiness, and risk-based quality management frameworks for clinical development and pharmacovigilance.
Domain
Life Sciences / Clinical Trials / Pharmacovigilance
Required skills
GCP and GVP regulation expertise, Quality by Design, risk-based quality management, inspection readiness, CAPA management, global team leadership, budget management, CRO/vendor oversight.
Preferred skills
Advanced degree or certification in Quality/GCP/GVP, experience with ICH E6(R3) and EU GVP frameworks, track record with health-authority inspections and remediation.
Technologies
QMS, Pharmacovigilance System Master File, computerised systems
Responsibilities
Set strategy and operating model for Clinical QA and PV QA; embed Quality by Design and risk-based quality management; assure quality systems and integration with enterprise QMS; oversee clinical safety interfaces (SAE, SUSAR, reporting); lead global framework for significant quality issues and CAPAs; lead GCP and GVP inspection readiness.
Seniority
Senior, hands-on IC with strategic leadership