Senior Manager Quality Compliance (Rare Disease)

Role: Serve as a GCP Subject Matter Expert providing independent quality oversight across all stages of clinical development at Amgen, ensuring compliance with regulations and best practices. Responsibilities: conduct risk-based GCP audits (investigator sites, vendors, study level); manage regulatory inspections and responses; oversee risk assessment tools; support program leaders in quality risk reviews; conduct vendor qualifications; analyze quality metrics; develop TA-specific QA plans; support clinical trial teams with deviation and CAPA management; innovate oversight methodologies leveraging data analytics and AI; review protocols for risk mitigation. Requirements: Doctorate with 2+ years, Master’s with 4+ years, Bachelor’s with 6+ years, or equivalent experience in biopharma quality, operations, or compliance, especially in clinical research. Preferred: BS in life sciences, advanced degrees, QA certifications, 7+ years in biotech/pharma QA, GCP audit experience, regulatory inspection support, leadership/mentoring, electronic QMS expertise. High-value specifics: focus on clinical trial GCP compliance, risk-based quality oversight, regulatory inspection readiness, and use of digital tools; therapeutic areas implied include Oncology, Inflammation, Rare Disease; development stage includes clinical trials; platform familiarity with GCP, GLP, GPvP. Work setup: not specified; travel requirements not detailed.