Director, Manufacturing Process & Technical Quality - CGT

Vertex Pharmaceuticals seeks a Director of Manufacturing Process & Technical Quality for cell and gene therapy programs. This role provides quality leadership and technical oversight across development, commercialization, and post-approval lifecycle management, ensuring compliance with global regulatory requirements and internal quality standards.

Responsibilities

• Translate quality strategy into compliant execution plans and ensure alignment with Vertex Quality Management System
• Provide end-to-end quality oversight from development through commercialization and post-approval lifecycle management
• Lead quality readiness assessments for process scale-up, technology transfer, validation, and commercial launch
• Identify, assess, and mitigate product, process, and compliance risks; represent quality in program governance
• Lead, mentor, and develop quality team members while managing budgets and cross-functional resource deployment

Requirements

• Bachelor's degree in life sciences, biotechnology, engineering, or related field
• 10+ years progressive experience in Quality, manufacturing, or technical operations in biotech/pharma
• 3+ years direct leadership experience managing cross-functional teams and resources
• In-depth knowledge of global regulatory frameworks for cell and gene therapies (ICH, EU, FDA)
• Direct experience with NDA, BLA, or MAA submissions and regulatory inspections
• Technical expertise in AAV/cell technology, aseptic processing, and manufacturing science
• Demonstrated proficiency in root cause analysis, process improvement methodologies, and operational excellence

Compensation: $184,600 - $277,000