Associate Vice President, Quality

• Ensures proper quality oversight strategies of research activities and RBQM in clinical trials
• Lead a global team and manage all trials across the Amgen portfolio globally
• RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs
• RDQ has a key role in advancing data driven oversight capability across the organization
• Responsible for inspection readiness, inspection execution and follow up
• Expanding our capabilities beyond GCP compliance and audit mindset focus include: Biosimilars, Rare Disease, Precision Medicine, Digital technology, Labelling, Product Complaint/Safety Reporting, PASS Study Management, Clinical trial simplification, Data analytics, Metrics development, R&D activities in response to regulatory trends and external pressures, Quality and compliance oversight over Amgen General Medicine: cardiovascular, obesity
• Oncology, Inflammation and Biosimilar Portfolios
• RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design, critical to quality measures and risk-based quality assurance
• Oversight of FSP and ensures performance of vendors is adequately executed for each study
• Leads health authority inspection readiness and inspection strategy for clinical globally
• Expanding our capabilities beyond GLP compliance mindset to include: In-Vitro and Companion Diagnostics, Biomarkers, Lab services, Digital technology, Data analytics, Research studies internally and externally sourced, Research vendors including innovative technology vendors, lab facilities, Animal welfare, Health authority inspection readiness and inspection strategy for research

Doctorate degree and 7 years of Clinical & Research Quality experience OR Master's degree and 10 years of Clinical Quality experience OR Bachelor's degree and 12 years of Clinical Quality experience AND 7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• Experience leading a Clinical Quality Assurance Team with oversight responsibilities of large clinical trial programs across multiple therapeutic areas
• Experience delivering risk-based quality oversight programs in compliance with ICH guidelines and global regulatory requirements
• Working knowledge of the legal and regulatory environment, applicable laws, regulations, guidance, and health authority expectations globally for drug development
• Proven track record in management and subsequent response to health authority inspections

• 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 and bi-annual company-wide shutdowns
• Flexible work models where possible