Senior Director, Inspection Readiness

Ladders; United States; Remote; USD 160,000 - 200,000; Full time

Benefits offered by this job

Medical and dental insurance

Paid time off

401(k) with a generous match

Job summary

Ladders is seeking a Senior Director, Inspection Readiness to lead GCP compliance across clinical development programs. You will partner with clinical operations, quality, and vendor teams to identify gaps, strengthen readiness, and support registration and reporting activities.

This remote US-based role emphasizes risk-based oversight and audit-ready practices for study execution. The position requires extensive experience in inspection readiness, ICH-GCP, and regulatory inspections, with a

Qualifications

• Bachelor's degree in life sciences or related field (advanced degree preferred)
• 15+ years of clinical operations or related drug development experience focused on inspection readiness
• Deep understanding of ICH-GCP, clinical trial regulations, and quality systems
• Experience preparing for regulatory inspections and mock audits
• Strong knowledge of TMF and CRO/vendor oversight

Responsibilities

• Provide leadership for inspection readiness and GCP compliance across clinical studies
• Develop a risk-based inspection readiness framework supporting clinical development
• Assess inspection readiness of operational processes and address compliance gaps
• Coordinate and oversee clinical trial registration and reporting requirements
• Monitor compliance metrics, inspection readiness reviews, and remediation actions

Skills

Leadership

GCP knowledge

Regulatory expertise

Risk management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

TMF

CRO/vendor oversight

Job description

For our client, we are seeking a Senior Director, Inspection Readiness to join the team of a leader in the Pharmaceuticals & Biotech space.
This role will lead inspection readiness and GCP compliance efforts across clinical development programs, ensuring operational processes are prepared for regulatory scrutiny. You will partner closely with clinical operations, quality, and vendor teams to identify compliance gaps, strengthen readiness frameworks, and support accurate registration and reporting activities. The position is highly focused on risk-based oversight, remediation planning, and maintaining audit-ready practices that support successful clinical study execution.
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $160,000 – $200,000 annually

Responsibilities

• Provide leadership for inspection readiness and GCP compliance across clinical studies
• Develop a risk-based inspection readiness framework supporting clinical development
• Assess inspection readiness of operational processes and address compliance gaps
• Coordinate and oversee clinical trial registration and reporting requirements
• Monitor compliance metrics, inspection readiness reviews, and remediation actions

Qualifications

• Bachelor's degree in life sciences or a related field; advanced degree preferred
• 15+ years of clinical operations or related drug development experience, with a focus on inspection readiness
• Deep understanding of ICH-GCP, clinical trial regulations, and quality systems
• Experience preparing for regulatory inspections and mock audits
• Strong knowledge of clinical trial operations, including TMF and CRO/vendor oversight

Benefits

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

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.