Senior Director Cell & Genetic Therapies Quality - Personalized Medicine

Location: Boston, MA, United States. Hybrid work is available up to two days remotely per week, or the role may be performed on-site five days per week. The position requires 15% travel.

Salary: $213,600–$320,400 base salary per year, plus eligibility for an annual bonus and annual equity awards.

Company

Global biotechnology company focused on scientific innovation and the development of medicines for serious diseases.

What you will do

• Lead quality systems strategy for personalized medicine and advanced cell and gene therapy programs across clinical, launch, and commercial stages.
• Provide end-to-end compliance oversight for internal and external CGT quality operations.
• Oversee quality across the patient-specific CGT treatment journey, including GMP requests, escalations, and quality management reviews.
• Establish governance routines for compliance trends, operational performance, emerging risks, and mitigation plans.
• Partner with Global Quality, Manufacturing, MS&T, Regulatory, Commercial, Supply Chain, and digital stakeholders.
• Lead, mentor, and develop quality teams while driving continuous improvement and operational excellence.

Requirements

• Bachelor’s or master’s degree in engineering, life sciences, pharmaceutical sciences, or a related technical discipline.
• 15+ years of experience, including 7+ years in management or supervision, in a regulated pharmaceutical environment or equivalent experience.
• Experience with quality and compliance oversight for allogeneic or autologous cell manufacturing, personalized medicine, or related modalities from development through commercialization.
• 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 the Boston-based hybrid or on-site arrangement and travel 15%.

Culture & Benefits

• Hybrid flexibility or an on-site work arrangement under the company’s Flex program.
• Medical, dental, and vision benefits with paid time off and company shutdown periods in summer and winter.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Opportunities to apply advances in AI, technology, automation, and industry trends to improve decision-making and patient outcomes.