R&D Supplier Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Facilitate the qualification, oversight, and ongoing enhancement of suppliers that contribute to Amgen’s R&D pipeline.

• Implement supplier quality management procedures for R&D suppliers in accordance with GCP, GLP, and GPvP regulations.

• Supervise suppliers involved in providing, hosting, developing, validating, maintaining, or supporting GxP computerized systems.

• Perform risk-based supplier assessments, qualifications, audits, and lifecycle management, including quality agreements.

• Lead or assist in the qualification and continuous oversight of suppliers utilizing or supplying GxP computerized systems, interfaces, and devices.

• Evaluate and monitor supplier AI-enabled GxP computerized systems for adherence to procedural controls, policies, and standards.

• Plan, conduct, and document risk-based audits of supplier GxP computerized systems and quality processes.

• Assess supplier controls related to validation, data integrity, security, access management, change and configuration management, incidents, backup, recovery, business continuity, and decommissioning.

• Review quality and technical specifications in supplier contracts and quality agreements.

• Engage in supplier governance and periodic reviews; assess performance, validation status, changes, deviations, incidents, audit results, emerging risks, and CAPA effectiveness.

• Assist in maintaining inspection readiness and regulatory responses pertaining to supplier computerized systems.

• Monitor supplier performance, track KPIs, and escalate quality issues as needed.

• Organize and/or conduct supplier audits, manage findings, initiate quality records, and ensure timely closure of CAPAs.

• Keep supplier data updated in quality systems such as Veeva and TrackWise.

• Collaborate with suppliers on requirements, governance, and process improvement initiatives.

• Ensure compliance with procedures, perform quality checks, and contribute to ongoing improvement.

• Work together with R&D, Supply Chain, Sourcing, and QA teams on supplier quality strategies.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of experience in Science, Engineering, or a related field OR Bachelor’s degree with 4 years of experience in Science, Engineering, or a related field OR Associate’s degree with 8 years of experience in Science, Engineering, or a related field OR High school diploma / GED with 10 years of experience in Science, Engineering, or a related field.

• Familiarity with GxP, ISO standards, and regulatory requirements applicable to R&D suppliers.

• Proficient in supplier quality risk assessment tools and audit methodologies.

• Understanding of computerized system validation and assurance principles.

• Knowledge of risk-based system lifecycle practices and standards for electronic records, electronic signatures, audit trails, and data integrity.

• Experience in assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers.

• Capability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance metrics.

• Experience and expertise in supervising AI-enabled GxP systems, encompassing risk assessment, governance, validation, data integrity, and ongoing supplier monitoring.

• Exceptional written and verbal communication skills.

• Ability to collaborate effectively within cross-functional teams and a matrixed environment.

• Strong problem-solving and critical thinking skills.

• Detail-oriented with a focus on continuous improvement.

• Proactive skills in collaboration and relationship-building.

• Ability to manage multiple priorities and deliver results within deadlines.

• Sponsorship for this position is not assured.

🏝️ Benefits

• Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance options.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Support for work/life balance.

• Up to 10% domestic and international travel may be required for supplier engagements and audits.