General Summary Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence supports Global Clinical Operations (GCO) audit/inspection management by planning, coordinating, and providing pre/post inspection support to ensure compliance with health authority regulations (e.g., FDA, EMA). Contributes to regulatory intelligence and helps build sustained inspection readiness. Responsibilities Lead inspection readiness/preparation for GCO (SME training/prep; back‑room support; manage back‑room during inspections). Risk‑analyze and implement readiness strategy/program; provide lessons learned after each inspection. Contribute to audit/inspection planning, response generation; participate in internal process audits. In collaboration with AIM, develop/approve annual internal audit schedule. Oversee GCO quality events; support CAPA plans and investigations; ensure remediation and implementation. Manage/communicate lessons learned across studies; drive continuous improvement. Collaborate cross‑functionally with GCQ, Regulatory Affairs, GPS; execute business strategy; serve as SME. Mentor junior staff/FSP personnel; people management (may include financial/account and HR responsibilities). Qualifications & Requirements Advanced understanding of GCP, CFR, ICH, and health authority regulations. 10 years biopharmaceutical industry experience (or equivalent); 3 years supervisor/management experience. Demonstrated inspection readiness leadership across multiple agencies (FDA, EMA, MHRA, PMDA, CDE). Experience applying risk‑based quality (e.g., QbD) in regulated/pharmaceutical environments. Knowledge & Skills Expert in inspection concepts; strong analytical/detail orientation; advanced tools/process knowledge; results oriented; strong communication; global/cross‑functional collaboration. Compensation & Benefits Pay range: $184,000–$276,000; annual bonus and annual equity awards. Remote‑Eligible (Remote/Hybrid/On‑Site options). Application Instructions For accommodation requests: #J-18808-Ljbffr