R&D Supplier Quality Manager: GxP & AI Systems

Amgen; United States; Remote; USD 104,000 - 141,000; Full time

Job summary

Amgen is seeking a highly motivated R&D Supplier Quality Manager to lead risk-based supplier assessments, qualification and lifecycle oversight of GxP systems supporting preclinical and clinical activities.

You will partner with Quality, Procurement, R&D, Information Systems, Cybersecurity, and process owners to ensure data integrity, patient safety, regulatory compliance, and continuous improvement across the supplier lifecycle, with travel up to 10%.

Qualifications

• Required advanced degree with related field experience.
• Experience in GxP validation, data integrity, electronic records and signatures.
• Ability to oversee AI-enabled GxP systems and supplier governance.
• Strong cross-functional collaboration and communication skills.
• Knowledge of regulatory expectations for R&D suppliers.

Responsibilities

• Conduct risk-based supplier assessments, qualification and lifecycle management.
• Oversee GxP computerized systems, validation, and change controls.
• Perform supplier audits, CAPA and risk mitigation activities.
• Review quality agreements, data retention and regulatory readiness.
• Collaborate with Quality, Procurement, R&D, IT, and business process owners.

Skills

GxP knowledge

AI-enabled GxP systems

Audits & CAPA

Quality risk assessment

Cross-functional collaboration

Education

Doctorate degree

Master’s degree with related experience

Bachelor’s degree with related experience

Associate’s degree with related experience

High school diploma / GED with related experience

Tools

Veeva

TrackWise

Job description

Amgen is seeking a highly motivated R&D Supplier Quality Manager to lead risk-based supplier assessments, qualification and lifecycle oversight of GxP systems supporting preclinical and clinical activities.

You will partner with Quality, Procurement, R&D, Information Systems, Cybersecurity, and process owners to ensure data integrity, patient safety, regulatory compliance, and continuous improvement across the supplier lifecycle, with travel up to 10%.