(Sr.) Director, GCP & GLP QA

Regenxbio(3 days ago)

Rockville, MDOnsiteFull TimeSenior$190,000 - $330,000Quality Assurance

About this role

REGENXBIO is seeking a senior-level Director to oversee GCP and GLP quality assurance for pre-clinical activities and clinical trial operations in the biopharma field. The role involves ensuring regulatory compliance, managing audits, and fostering a culture of quality across multiple functional teams. It offers an opportunity to contribute to innovative gene therapy products within a growing organization.

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Required Skills

GCP
GLP
GxP
Auditing
Regulatory Compliance
Quality Systems
Clinical Data
CAPA
ICH Guidelines
FDA Regulations

About Regenxbio

ultipro.com

UltiPro (originally from Ultimate Software) is a cloud-based human capital management (HCM) platform that delivers HR, payroll, talent management, and workforce management tools for organizations. The SaaS suite includes payroll processing, benefits administration, recruiting and onboarding, performance management, time & attendance, and people analytics in a unified system. Known for strong customer support and analytics-driven HR workflows, UltiPro was developed by Ultimate Software, which merged with Kronos to form UKG (Ultimate Kronos Group) and continues in that product portfolio (often branded UKG Pro). Enterprises across industries use it to streamline HR operations and improve employee experience.

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