Senior Manager, GCP, GLP Supplier Quality

Role: Senior Manager, GCP/GLP Supplier Quality, responsible for leading global supplier quality management activities supporting clinical and nonclinical GCP and GLP suppliers. Objectives include ensuring regulatory compliance, risk-based oversight, and continuous improvement of supplier performance. Responsibilities encompass supplier qualification, onboarding, risk assessment, lifecycle management, performance monitoring, and quality event handling. You will also develop and manage quality agreements, support inspection readiness, and conduct audits of GCP and GLP suppliers. Requirements: Bachelor's degree in Chemistry, Engineering, Life Sciences, with 12-15 years supporting GCP/GLP activities; strong experience with supplier oversight, audits, qualification, CAPA, risk management, and familiarity with global regulatory standards (FDA, EMA, ICH, GLP guidelines). Preferred skills include GCP auditing certification and global clinical development experience. High-Value: extensive GCP/GLP compliance knowledge, supplier management expertise, and experience supporting global regulatory inspections. Work setup: fully remote with occasional domestic/international travel (~20%).