R&D Supplier Quality Lead – GxP Compliance & AI Systems

BioSpace; Washington (District of Columbia); Sur place; USD 170 000 - 210 000; Plein temps

Résumé du poste

Amgen is seeking a highly experienced R&D Supplier Quality Manager to oversee supplier qualification, audits, and lifecycle management for GxP systems across preclinical and clinical activities. You will partner with Quality, Procurement, R&D, IS, Cybersecurity, Privacy and business process owners to ensure data integrity, patient safety, and regulatory readiness.

Responsibilities include risk-based supplier assessments, audits of GxP computerized systems, managing CAPAs, contract reviews, and

Qualifications

• Doctorate degree OR
• Masters degree and 2 years of Science, Engineering, or experience in a related field OR
• Bachelors degree and 4 years of Science, Engineering, or experience in a related field OR
• Associates degree and 8 years of Science, Engineering, or experience in a related field OR
• High school diploma / GED and 10 years of Science, Engineering, or experience in a related field

Responsabilités

• Conduct risk-based supplier assessments, qualification, audit and lifecycle management, including quality agreements across various R&D service categories.
• Lead or support risk-based qualification and ongoing oversight of suppliers that utilize and/or provide GxP computerized systems, interfaces and devices to support clinical and preclinical activities.
• Assessment and oversight of supplier AI-enabled GXP computerized systems used to support clinical and preclinical activities ensuring compliance to defined procedural controls, policies and standards.
• Plan, lead, and document risk‑based audits of supplier GxP computerized systems and associated quality processes to assess regulatory compliance, validation and lifecycle controls, data integrity, security, and the effectiveness of corrective and preventive actions.
• Assess supplier quality systems and controls for computerized system lifecycle management, including validation, data integrity, security, access management, change and configuration management, incident and problem management, backup, recovery, business continuity, and decommissioning.
• Review risk‑appropriate quality and technical requirements in supplier contracts and quality agreements, including validation documentation, audit trails, electronic records and signatures, subcontractor controls, regulatory inspection support, data ownership, data retention, and notification of significant changes or incidents.
• Participate in supplier governance and periodic reviews; evaluate service performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness, and elevate material GxP or data integrity concerns.
• Support inspection readiness and regulatory responses related to suppliers computerized systems; partner with system owners and subject‑matter experts on supplier risk acceptance, remediation, continuity, transition, and exit decisions.
• Monitor supplier performance, track KPIs, and elevate quality issues when appropriate.
• Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure.
• Maintain supplier data in quality systems (e.g., Veeva, TrackWise) to ensure accuracy and inspection readiness.
• Engage with suppliers to align requirements, governance and process improvement initiatives.
• Ensure compliance with procedures, perform quality checks, and contribute to continuous improvement.
• Collaborate with internal teams (R&D, Supply Chain, Sourcing, QA) to assist in the development and execution of supplier quality strategies.

Description du poste

Amgen is seeking a highly experienced R&D Supplier Quality Manager to oversee supplier qualification, audits, and lifecycle management for GxP systems across preclinical and clinical activities. You will partner with Quality, Procurement, R&D, IS, Cybersecurity, Privacy and business process owners to ensure data integrity, patient safety, and regulatory readiness.

Responsibilities include risk-based supplier assessments, audits of GxP computerized systems, managing CAPAs, contract reviews, and