GCP Quality Compliance Manager

• Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program, including protocol development, database lock, and regulatory submissions/ approvals
• Oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials
• Serve as the GCP quality SME, providing independent quality guidance for clinical trial activities aligned with global regulations and best practices
• Oversee quality and compliance across all stages of clinical development programs, including risk management through RACT and protection of patient safety, rights, and data integrity
• Support clinical trial teams with quality management activities such as deviations/CAPAs, inspection readiness, serious breaches, privacy issues, and regulatory inspection responses
• Review protocols and trial processes to drive simplification, apply lessons learned, and identify critical data and operational risks
• Implement innovative, risk-based quality oversight approaches using advanced analytics, AI, and NLP methodologies
• Monitor and analyze quality metrics and trends, identify gaps, and recommend corrective and preventive actions to stakeholders and senior leadership
• Provide vendor quality oversight and support regional compliance with local regulations and regulatory requirements
• Plan, conduct, and report risk-based GCP audits, including investigator site, affiliate, and study-level audits

• Strong experience in GCP within Clinical R&D, Quality, or Study Management environments
• Knowledge of electronic Quality Management Systems (e.g., Veeva, TrackWise) and clinical trial oversight processes
• Solid understanding of clinical development, protocol execution, regulatory submissions, and inspection management
• Proven ability to support operational and quality oversight of clinical trials from development through submission
• Excellent written and verbal communication skills, including business writing and stakeholder engagement
• Strong analytical, critical-thinking, and problem-solving capabilities with the ability to simplify complex processes and technical concepts
• Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry is preferred
• Degree educated

Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits