Clinical Quality Compliance Senior Manager

• Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance
• Oversee quality across all clinical development stages
• Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies)
• Support regulatory inspections and guide responses, including root cause analysis and CAPAs
• Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial
• Facilitate monthly quality risk reviews with clinical program leaders
• Manage audit findings, deviations, and CAPA responses
• Ensure regional compliance with local regulations and support vendor evaluations
• Analyze data quality trends, identify gaps, and implement corrective actions
• Oversee technologies for endpoint data collection (e.g., biomarkers, imaging)
• Develop and execute TA-specific QA plans and protocol-specific audit strategies
• Support quality management activities including deviations, breaches, and inspection readiness
• Drive innovation in quality oversight using data analytics, AI, and NLP
• Review protocols to simplify design and identify critical data/processes
• Manage analytical tools and data trends to address site/regional quality gaps
• Provide oversight for key sites in collaboration with regional operations
• Conduct Quality Partnership Visit at key sites within the country/Region
• Share best practices and compliance insights with stakeholders
• Offer independent quality consultation and escalate issues as needed
• Support local vendor assessments and pre-inspection activities
• Conduct regional risk assessments for audit planning
• Stay current on regulatory trends and deliver ongoing training

• Doctorate degree and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility
• Master’s degree and 4 years of the previous mentioned experience
• Bachelor’s degree and 6 years of the previous mentioned experience
• Associate’s degree and 10 years of the previous mentioned experience
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
• Thorough understanding of Clinical R&D activities and Global Regulations
• Experience with Regulatory Submission and Inspection Management procedures
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
• Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal
• Excellent verbal and written communication skills, including strong business writing abilities and active listening
• Able to understand and articulate technical concepts and literature in spoken and written English
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
• Self-driven with strong analytical, critical-thinking, prioritization, and decision-making abilities

Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal

• Vast opportunities to learn, develop, and move up and across our global organization
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits
• Flexible work arrangements