Who we are

REGENXBIO is an exceptional place to work.  You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans.  Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do.  We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity

As the Quality Assurance Compliance Specialist, you will audit and maintain GXP quality systems to support development phase gene therapy operations.  You will support the internal and external audit programs to ensure Quality standards and business expectations are met. Additionally, you will work directly with external partners and internal resources to assure compliance with GXP regulations and continuous improvement of Quality Systems.

What you’ll be doing

• Support implementation and routine management of core Quality Systems
• Interpret regulations and guidance documents and apply to practical situations.
• Provide QA support for raw material item approval, receipt and test specifications.
• Maintain approved supplier list and supplier records.
• Conduct and participate in scheduled audits of suppliers.
• Manage supplier audit schedules, communicate with suppliers as needed to ensure audit CAPA completion and audit close-out.
• Generate, review, and implement procedures as needed.
• Track and trend supplier changes and performance
• Perform quality transactions in inventory management systems for GXP materials.
• Support GMP readiness activities for the new manufacturing facility, laboratories, and support areas
• Provide QA support for risk identification, assessment, and remediation.
• Review change controls, complaints, and investigations, demonstrating scientifically sound and compliant resolution.
• Serve as the QA representative on cross-functional project teams.
• Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across the organization to influence and implement solutions.
• Interpret regulations and guidance documents and apply to practical situations.
• Independently plan and perform assigned responsibilities and projects with minimal supervision.
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.