Role OverviewJoin Amgen’s Mission of Serving Patients. 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.
What You Will Do
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.
Why It Might Be a Fit
The dynamic professional we seek is a collaborative partner with these qualifications: 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.
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
- 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.
Benefits
- 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
- 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
]]>