Executive Director Quality, 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

Position Summary:

• Executive leader defining and executing the CGT Quality vision, operating model, and organizational strategy; ensure quality readiness from early development through commercialization; build scalable, inspection-ready quality capabilities across internal sites and external partners.

Responsibilities:

• Define and execute long-term CGT Quality strategy; build scalable quality operating models; drive enterprise-wide quality transformation.
• Lead/represent Quality in Cell & Genetic Programs; partner to support health authority requests and market authorization submissions.
• Oversee process and analytical technical transfers; lead CGT quality and technical risk management and mitigation plans.
• Develop integrated digital quality capabilities for proactive quality management.
• Ensure quality readiness through commercialization and lifecycle management; establish launch and global expansion quality strategies; lead quality governance for PPQ, process validation, comparability, and readiness activities.
• Establish quality oversight for internal and CRO/CMO operations (manufacturing/distribution); serve as executive sponsor for health authority inspections; lead internal/external partner compliance and operational excellence.
• Build and develop global quality organization; succession planning and talent development; foster inclusive continuous-improvement culture; manage budgets/resources/organizational design and strategic investments.

Qualifications:

• Education: Master’s degree or PhD in biotechnical/life science (or comparable background).
• Experience: 15+ years in quality/technical experience in pharmaceutical development and commercial manufacture; 10+ years in management/supervisory role.

Required Skills/Knowledge:

• In-depth global regulatory knowledge across GxP lifecycle in cell/gene therapy and/or biologics.
• Deep expertise in cell technology, aseptic manufacturing, analytical assays, processing, fill/finish, and testing.
• Experience with gene/cell therapy regulatory documentation and inspections; strategic planning/execution; leadership across global manufacturing networks; risk management, critical thinking, and strong communication/influencing.