Senior GMP Supplier Quality Specialist

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet in Raleigh, NC seeks a Supplier Quality Specialist to provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials and external laboratories. You will manage supplier qualification, audits, CAPA follow-up, and risk mitigation in alignment with GMP and internal procedures.

You will collaborate with cross-functional SMEs to investigate deviations, support change controls, and maintain quality agreements, ensuring supply continuity and data integrity

Qualifications

• Bachelor’s degree in a life sciences or engineering field.
• 5+ years of QA experience in GMP-regulated environments.
• Experience authoring, reviewing, and maintaining GMP documentation.

Responsibilities

• Provide ongoing quality oversight of suppliers for GMP manufacturing.
• Support supplier qualification, re-qualification, and lifecycle management.
• Support and/or conduct supplier audits (remote and on-site) and follow-up.
• Maintain oversight of critical and sole-source suppliers with risk mitigation.
• Manage supplier change notifications with documentation and risk assessment.
• Ensure Quality Agreements remain current and are drafted for new/legacy suppliers.
• Provide Supplier Quality impact assessments for GMP changes.
• Ensure supplier deviations and OOS are logged, investigated, and closed.
• Collaborate with cross-functional SMEs to investigate root causes and remediation.
• Initiate and monitor SCARs and annual product quality reviews.

Skills

Quality Assurance

GMP Knowledge

Regulatory Knowledge

Auditing

CAPA

Change Control

Cross-functional

Documentation

Education

Bachelor's Degree

ASQ CQA Certification

Life Sciences/Engineering Degree

Job description

Guerbet in Raleigh, NC seeks a Supplier Quality Specialist to provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials and external laboratories. You will manage supplier qualification, audits, CAPA follow-up, and risk mitigation in alignment with GMP and internal procedures.

You will collaborate with cross-functional SMEs to investigate deviations, support change controls, and maintain quality agreements, ensuring supply continuity and data integrity