Director Clinical Quality & Development Operations Inspection Excellence

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.

• 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).

• 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.

• Expert in inspection concepts; strong analytical/detail orientation; advanced tools/process knowledge; results oriented; strong communication; global/cross‑functional collaboration.

Pay range: $184,000–$276,000; annual bonus and annual equity awards.

Remote‑Eligible (Remote/Hybrid/On‑Site options).

For accommodation requests: A