Remote Regulatory affairs Jobs • Auditing

As a Manager, Clinical Quality Compliance, you will perform and lead audits of clinical investigator sites, internal GCP systems/processes, external vendors, and clinical trial documents. Identify and report systematic issues and areas for improvement. Ensure appropriate corrective and preventative actions have been committed to by auditees. Approximately 50% travel is required.

Ensures corporate and regulatory compliance for the company's quality assurance and food safety initiatives by proactively providing technical expertise, training, and operational support across business segments. Leads incident response efforts and supports third-party food safety audit programs. Supports successful onboarding of new units and operational leaders, requiring 50%-80% travel.

Oversee the development, implementation, and maintenance of the healthcare compliance program at GeneDx, a commercial genomic testing laboratory. Ensure that laboratory operations, billing practices, and regulatory reporting align with applicable healthcare laws, regulations, and accreditation standards. Serve as a subject matter expert and key advisor to internal stakeholders on regulatory risk, operational compliance, and ethical business conduct.