Senior Manager, GCP Quality Assurance
Core
Ensure quality and compliance of clinical trials with GCP regulations, ICH guidelines, and industry standards to promote patient safety and data integrity.
Role type
Senior Manager, GCP Quality Assurance
Builds
Clinical trial quality systems, audit reports, and CAPA processes for biopharmaceutical R&D
Domain
Biopharmaceuticals / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP compliance, clinical trial auditing, risk-based quality management, CAPA management, inspection readiness, eQMS usage, cross-functional collaboration
Preferred skills
GVP/GLP knowledge, health authority inspection support, study management experience
Technologies
Veeva
Responsibilities
Develop and maintain clinical quality systems, manage external vendor quality audits, lead quality event investigations, review clinical study documents, support global agency inspections, mentor team members
Seniority
Senior, hands-on IC with management responsibilities
