Senior Director, CGT Quality Systems, Personalized Medicine (Biotech)

TL;DR

Senior Director, CGT Quality Systems, Personalized Medicine (Biotech): Leading quality systems, compliance, and governance for personalized medicine and advanced cell and gene therapy programs across the full patient treatment journey with an accent on risk-based oversight, regulatory compliance, and operational excellence. Focus on building scalable quality processes, governing patient-specific treatment requests, strengthening data integrity, and using advanced analytics and artificial intelligence to improve decision-making.

Location: Boston, Massachusetts, United States; hybrid work with up to two remote days per week or onsite work five days per week. The role requires 15% travel.

Salary: $180,800–$271,200 base salary, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of therapies for serious diseases.

What you will do

• Lead quality systems strategy and execution for personalized medicine and advanced cell and gene therapy programs across clinical, launch, and commercial stages.
• Provide end-to-end quality and compliance oversight for internal and external CGT operations.
• Establish governance routines to monitor compliance trends, operational performance, emerging risks, and mitigation plans.
• Oversee quality across the patient treatment journey, including patient-specific GMP requests and Quality Management Review Boards.
• Partner with digital and cross-functional stakeholders to implement lifecycle management and advanced reporting solutions.
• Lead, mentor, and develop quality professionals while driving collaboration, accountability, and continuous improvement.

Requirements

• Bachelor’s degree in engineering, life sciences, pharmaceutical sciences, or a related technical discipline.
• 15+ years of experience, including 7+ years in management or supervisory roles, in a regulated pharmaceutical environment.
• Broad experience with quality and compliance oversight for allogeneic or autologous cell manufacturing, personalized medicine, or related modalities.
• In-depth knowledge of global health authority expectations and GxP requirements for cell and gene therapy, biologics, and advanced therapy products.
• Strong enterprise influence, executive presence, communication, risk management, critical thinking, and problem-solving skills.
• Ability to work in a hybrid or onsite arrangement in Boston, Massachusetts, with 15% travel.

Nice to have

• Master’s degree in business analytics, management, life sciences, or a related field.
• Experience using artificial intelligence and advanced digital reporting in quality operations.

Culture & Benefits

• Hybrid flexibility of up to two remote days per week or an onsite work option.
• Medical, dental, and vision coverage with resources supporting financial, family, and personal wellbeing.
• Generous paid time off, including summer and winter company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Inclusive workplace with equal employment opportunity and reasonable accommodation support.