Senior Supplier Quality Specialist – GMP & Compliance

Guerbet; Raleigh (NC); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Guerbet is seeking a Supplier Quality Specialist to ensure GMP materials meet all quality and regulatory expectations at our Raleigh facility. You will partner with cross-functional teams to drive supplier qualification, audits, CAPA, and change management to safeguard product quality and patient safety.

The role requires a strong background in GMP documentation and risk-based supplier oversight, plus the ability to lead audits and collaborate with Regulatory, Supply Chain, and Manufacturing

Qualificações

• Bachelor’s degree and 5+ years QA in GMP environment.
• Experience authoring and maintaining GMP documents.
• Strong GMP/regulatory knowledge (FDA, EMA, ICH).
• Ability to manage priorities and timelines with attention to detail.

Responsabilidades

• Provide ongoing supplier quality oversight for GMP materials.
• Support supplier qualification, re-qualification and lifecycle management.
• Lead supplier audits (remote and on-site) and CAPA follow-up.
• Maintain critical and single-source supplier oversight and risk mitigation.
• Manage supplier change notifications and quality agreements.

Conhecimentos

GMP knowledge

QA documentation

Audit experience

Regulatory knowledge

Formação académica

Bachelor's Degree

Descrição da oferta de emprego

Guerbet is seeking a Supplier Quality Specialist to ensure GMP materials meet all quality and regulatory expectations at our Raleigh facility. You will partner with cross-functional teams to drive supplier qualification, audits, CAPA, and change management to safeguard product quality and patient safety.

The role requires a strong background in GMP documentation and risk-based supplier oversight, plus the ability to lead audits and collaborate with Regulatory, Supply Chain, and Manufacturing