Director, Manufacturing Process & Technical Quality - CGT (Cell and Gene Therapy)

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 with ad hoc flexibility. Domestic and international travel of up to 25% may be required.

Base salary: $184,600–$277,000 per year, plus potential annual bonus and equity awards.

Company

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

What you will do

• Lead end-to-end Quality oversight for Cell & Gene Therapies programs from development through commercialization and post-approval lifecycle management.
• Translate Quality strategy into compliant execution plans, phase-appropriate standards, governance, and deliverables.
• Lead Quality activities for technical transfer, comparability, process performance qualification, validation, regulatory submissions, launch, and lifecycle management.
• Drive manufacturing and operational readiness across process scale-up, technology and analytical transfer, launch, and commercial operations.
• Identify and mitigate product, process, compliance, and supply risks, including oversight of deviations, OOS results, CAPAs, changes, and emerging trends.
• Lead, coach, and develop Quality professionals while managing resources, budgets, external support, and cross-functional priorities.

Requirements

• Bachelor’s degree in life sciences, biotechnology, engineering, or a related discipline; a master’s degree or equivalent relevant experience is preferred.
• Typically 10+ years of progressive experience in Quality, manufacturing, technical operations, development, or Quality Control within biotechnology or pharmaceuticals.
• At least 3 years of leadership experience, including direct people leadership or accountability for cross-functional teams and resource deployment.
• In-depth knowledge of global regulatory agencies and GxP requirements across the Cell & Gene Therapy and/or biologics lifecycle, including FDA, EU, and ICH expectations.
• Experience with regulators, including NDA, BLA, or MAA submissions and inspections, plus knowledge of AAV or cell technologies, aseptic processing, process development, and manufacturing science.
• Experience with root cause analysis, data analytics, Lean, DMAIC, Six Sigma, critical thinking, influencing, negotiation, and matrix leadership.

Culture & Benefits

• Continuous learning focused on AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Equal employment opportunity and reasonable accommodation support.