R&D Clinical Quality Compliance Senior Manager

Responsibilities

• Act as a key advisor to study teams throughout the clinical trial life cycle, providing objective quality input regarding GCP and SOP compliance
• Review clinical study protocols and amendments with a focus on Quality by Design (QbD) principles
• Lead study risk assessment activities and participate in Risk Based Quality Management (RBQM) initiatives
• Direct study teams through the management of complex quality issues and analyze quality data metrics
• Support clinical study teams with inspection readiness, audit scheduling, and regulatory submission preparation
• Mentor junior colleagues and provide line management responsibilities as applicable
• Utilize AI tools and technologies to streamline workflows and drive process automation

Requirements

• Master’s Degree in Life Sciences, Medical, or a related appropriate discipline
• 15-18 years of experience in the Biotech, Pharmaceutical, or CRO industry
• In-depth knowledge of ICH GCP and global clinical R&D regulations
• Extensive experience in Quality Management, Quality Assurance, or risk-based quality oversight
• Proficiency with electronic QMS tools, specifically Veeva Vault and eTMF
• Strong expertise in regulatory submission and inspection readiness procedures
• Excellent analytical, critical-thinking, and business communication skills

About the Company

Amgen is a leading global biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. Since 1980, Amgen has focused on high unmet medical needs, leveraging advanced human genetics and biologics manufacturing expertise to deliver innovative human therapeutics to millions of patients worldwide.