Senior Director, Inspection Readiness

📋 Description

• Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical
• Develop, implement, and maintain a risk-based, scalable inspection readiness framework that
• Assess the inspection readiness of clinical studies and operational processes, including
• Proactively identify compliance, process, documentation, and oversight gaps; evaluate risk and
• Provide cross-functional Sponsor oversight and coordination of clinical trial registration and
• Establish and oversee processes for tracking applicable reporting requirements, accountabilities

🎯 Requirements

• 15+ years of clinical operations, clinical quality, or related drug-development experience, with
• Deep knowledge of ICH-GCP, Sponsor responsibilities, applicable clinical trial regulations, quality
• Demonstrated experience preparing for and supporting regulatory inspections, Sponsor audits, mock
• Strong understanding of end-to-end clinical trial operations across study start-up, conduct
• Experience with clinical trial registration and results disclosure requirements, including
• Demonstrated experience reviewing, developing, or improving SOPs, work instructions, controlled

🎁 Benefits

• Competitive salaries
• Medical and dental insurance
• Paid time off
• 401(k) with a generous company match