Senior Manager, R&D Quality Assurance
Core
Lead R&D Quality Assurance oversight for assigned clinical studies, ensuring compliance with GCP, protocols, and regulations while managing audit and inspection-readiness activities.
Role type
Senior Manager, R&D Quality Assurance (Clinical)
Builds
Clinical studies compliant with GCP and regulatory standards
Domain
Pharmaceutical R&D / Clinical Trials
Required skills
GCP compliance, clinical trial oversight, audit leadership, inspection readiness, risk mitigation, CAPA management, cross-functional collaboration, regulatory guidance interpretation, team coaching
Preferred skills
Late-phase clinical trial experience, leading audits, direct inspection experience, knowledge of clinical supply chain, clinical operations, monitoring, regulatory affairs, drug safety, data management, statistics
Technologies
GCP regulations, FDA/EMA/PMDA guidelines
Responsibilities
Perform R&D QA Program Lead role for assigned clinical studies; provide quality oversight and manage risk escalation; lead GCP audits (investigator site, vendor, study, process); lead inspection-readiness activities for FDA, EMA, PMDA; establish relationships with internal leads, study teams, and vendors; maintain knowledge of global GCP regulations; provide guidance and coaching to junior R&D QA staff
Seniority
Senior Manager, hands-on leadership with team oversight
