R&D Supplier Quality Leader – GxP Systems & Risk

Amgen; United States; Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Amgen is seeking a highly capable R&D Supplier Quality Manager to drive qualification, oversight, and continuous improvement of suppliers across the R&D pipeline. You will collaborate with Quality, Procurement, R&D, IS, Cybersecurity and business process owners to ensure data integrity, patient safety, and regulatory compliance.

Travel up to 10% may be required for supplier engagements and audits, and you will lead risk-based supplier assessments, audits, and lifecycle management of

Qualifications

• PhD, or Master’s with 2+ years in science/engineering.
• Bachelor’s degree with 4+ years in science/engineering.
• Experience with GxP, ISO standards, and regulatory expectations.

Responsabilités

• Conduct risk-based supplier assessments, qualification, audit and lifecycle management.
• Lead risk-based qualification of GxP computerized systems and devices.
• Plan, lead and document risk-based audits of supplier systems and processes.
• Review supplier quality systems for lifecycle management and data integrity.
• Engage with internal teams to develop and execute supplier quality strategies.
• Support inspection readiness and regulatory responses related to supplier systems.

Connaissances

GxP knowledge

Audits

Data integrity

Regulatory compliance

AI-enabled GxP

Cross-functional collaboration

Problem solving

Communication skills

Detail oriented

Formation

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Description du poste

Amgen is seeking a highly capable R&D Supplier Quality Manager to drive qualification, oversight, and continuous improvement of suppliers across the R&D pipeline. You will collaborate with Quality, Procurement, R&D, IS, Cybersecurity and business process owners to ensure data integrity, patient safety, and regulatory compliance.

Travel up to 10% may be required for supplier engagements and audits, and you will lead risk-based supplier assessments, audits, and lifecycle management of