Senior GMP Auditor for Biotech & Supplier Compliance

United Therapeutics; Nouvelle-Calédonie; Presencial; EUR 77.064 - 118.223; Jornada completa

Descripción de la vacante

United Therapeutics is seeking an Auditor II to ensure site quality systems and vendor practices meet regulatory standards. You will conduct audits, develop risk-based plans, and support regulatory inspections across UT sites and approved vendors.

The role requires 5+ years in auditing/supplier management, strong cGMP/ISO knowledge, and the ability to collaborate cross-functionally. Expect up to 50% travel and work near RTP NC or Silver Spring MD.

Formación

• Bachelor’s degree in science or engineering required.
• 5+ years auditing/supplier management in regulated industry.
• Strong knowledge of US cGMP and ISO/ICH standards.
• Passport valid or ability to obtain one.
• Excellent attention to detail and task ownership.
• Able to work independently and in teams.

Responsabilidades

• Conduct audits of quality management system elements across sites and vendors.
• Develop risk-based audit plans and produce detailed audit reports.
• Perform internal audits from development to commercialization.
• Assess current and potential GMP/GDP CMOs and vendors.
• Prepare vendor risk assessments and track quality history.
• Manage vendor list reviews and change notifications.
• Investigate quality issues and support regulatory inspections.
• Assist in vendor qualification for development projects.
• Monitor quality system performance and report findings.
• Review procedures to ensure regulatory compliance.

Conocimientos

Auditing

Supplier management

cGMP compliance

Regulatory knowledge

Cross-functional collaboration

Communication

MS Office

Travel readiness

Documentation

Quality systems

Educación

Bachelor’s Degree in science or engineering

Master’s Degree in science or engineering

PhD in a similar field

Herramientas

SAP

TrackWise Digital

MasterControl

Descripción del empleo

United Therapeutics is seeking an Auditor II to ensure site quality systems and vendor practices meet regulatory standards. You will conduct audits, develop risk-based plans, and support regulatory inspections across UT sites and approved vendors.

The role requires 5+ years in auditing/supplier management, strong cGMP/ISO knowledge, and the ability to collaborate cross-functionally. Expect up to 50% travel and work near RTP NC or Silver Spring MD.