Associate Director, Inspection Readiness

Scorpion Therapeutics; Princeton (NJ); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in Princeton, NJ is seeking an Associate Director, Inspection Readiness to support clinical trial operations by ensuring compliance and inspection preparedness across trials and service providers.

The role leads establishment and optimization of inspection frameworks, drives investigations of non-compliances, and collaborates with global teams to maintain readiness for GCP inspections.

Qualifications

• MSc or equivalent in life sciences, pharmacy, medicine, or related field.
• 10+ years of experience in clinical operations, quality, or compliance within pharma/biotech.
• Strong knowledge of GCP, FDA/EMA regulations, and clinical trial processes.
• Proven ability in project management and engaging stakeholders.
• Experience in process/system development and mentoring.

Responsibilities

• Establish and maintain inspection frameworks across trials and providers.
• Optimize digital tools to support inspection readiness.
• Lead investigations of non-compliances and root-cause analyses.
• Drive continuous assessment and improvement of trial readiness.
• Develop and deliver inspection training for teams.
• Support GCP inspections as Control Room Lead.
• Oversee quality events and compliance in clinical operations.

Skills

Project management

Stakeholder engagement

Mentoring

Education

MSc in Life Sciences, Pharmacy, Medicine, or related

Job description

Role: Associate Director, Inspection Readiness, supporting clinical trial operations by ensuring compliance and inspection preparedness across trials and service providers.

Responsibilities

• establish and maintain inspection frameworks
• optimize digital tools
• lead investigations of non-compliances
• drive continuous assessment and improvement of trial readiness
• develop inspection training
• support GCP inspections as Control Room Lead
• oversee quality events and compliance in clinical operations

Requirements

• MSc in Life Sciences, Pharmacy, Medicine, or related
• 10+ years in clinical operations, quality, or compliance within pharma/biotech
• strong knowledge of GCP, regulations (FDA, EMA, etc.), and clinical trial processes
• project management and stakeholder engagement skills
• experience in process/system development and mentoring

High Value

• clinical compliance
• inspection readiness
• GCP
• quality oversight
• global and cross-functional coordination
• regulatory adherence
• trial lifecycle

Work Setup

WorkSetup: not specified; likely hybrid or remote, given the global scope.