Global Quality Director, Cell & Gene Therapy

Scorpion Therapeutics; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Scorpion Therapeutics seeks an executive to define and execute the CGT Quality vision from early development through commercialization. You will build scalable quality capabilities across internal sites and external partners, ensuring inspection readiness and regulatory alignment across global operations.

You will lead the global quality strategy, govern inspections with health authorities, oversee process validation, comparability, and lifecycle management, and mentor a high-performing team

Qualifications

• 15+ years in quality/technical pharma development and manufacturing.
• 10+ years in management roles.
• Experience with gene/cell therapy regulatory documentation and inspections.

Responsibilities

• Define and execute long-term CGT Quality strategy and scalable operating models.
• Lead Quality in Cell & Genetic Programs and support health authority submissions.
• Oversee risk management, transfers, and process validation readiness.
• Develop digital quality capabilities for proactive management.
• Ensure readiness through commercialization and lifecycle management; govern PPQ and comparability.

Skills

GxP Lifecycle Knowledge

Global Regulatory Expertise

Leadership & People Management

Strategic Planning

Education

Master's/PhD in biotechnical or life sciences

Job description

Scorpion Therapeutics seeks an executive to define and execute the CGT Quality vision from early development through commercialization. You will build scalable quality capabilities across internal sites and external partners, ensuring inspection readiness and regulatory alignment across global operations.

You will lead the global quality strategy, govern inspections with health authorities, oversee process validation, comparability, and lifecycle management, and mentor a high-performing team