Manager-Quality Assurance Auditor- GCP- (Remote US)
Core
Lead risk-based quality audits across investigator sites, service providers, and internal processes to ensure clinical studies meet GCP compliance standards.
Role type
Manager, GCP Auditing
Builds
Clinical development quality assurance programs for global portfolio
Domain
Biopharmaceuticals / Clinical Development / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP audit execution, FDA/EU/ICH regulation interpretation, risk-based audit strategy, regulatory inspection support, cross-functional collaboration, stakeholder management, project management, mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Own end-to-end audit process (scheduling, preparation, reporting, follow-up), lead audits across sites and vendors, resolve GCP compliance issues, represent GDQA on cross-functional teams, interpret regulations for critical issues, support clinical study teams with audit strategies, participate in regulatory inspections, mentor new staff
Seniority
Manager, hands-on leadership
