R&D Supplier Quality Manager

Amgen • Thousand Oaks, CA

30d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualifications, oversight, and continuous improvement of suppliers that contribute to Amgen’s R&D pipeline and our mission to serve patients. In this role you will support the operational execution of supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations, including suppliers that provide, host, develop, validate, maintain, or support GxP computerized systems used to support regulated preclinical and clinical activities. Working cross-functionally with stakeholders across Quality, Procurement, R&D, Information Systems, Cybersecurity, Privacy, and business process owners, you will provide hands-on oversight of third-party suppliers to ensure compliance, data integrity, patient safety, risk mitigation, and continuous improvement across the supplier lifecycle.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Science, Engineering, or experience in a related field OR Bachelor’s degree and 4 years of Science, Engineering, or experience in a related field OR Associate’s 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

Nice To Haves

• Master’s degree or equivalent in Life Sciences or Engineering.
• Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers.
• Experience with supplier quality risk assessment tools and audit practices.
• Working knowledge of computerized system validation and assurance principles, risk-based system lifecycle practices, and applicable expectations for electronic records, electronic signatures, audit trails, and data integrity.
• Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers.
• Ability 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 data.
• Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring.
• Excellent written and verbal communication skills.
• Ability to work effectively in cross-functional teams and in a matrixed environment.
• Strong problem-solving and critical thinking abilities.
• Detail-oriented with a continuous improvement mindset.
• Proactive collaboration and relationship-building skills.
• Ability to manage multiple priorities and deliver results under timelines.

Responsibilities

• 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 escalate material GxP or data integrity concerns.
• Support inspection readiness and regulatory responses related to supplier’s 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 escalate 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed