Inspection Readiness Lead, Clinical Operations & GCP

Scorpion Therapeutics

Princeton (NJ)

Hybrid

USD 130,000 - 180,000

Full time

3 days ago

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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

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.

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