Executive Director, Manufacturing Operations – T1D

Vertex is driven by a shared commitment to transform the lives of patients with serious diseases. The Executive Director, Manufacturing Operations will play a critical leadership role in delivering on this mission by building and leading a global external manufacturing network for our Type 1 Diabetes cell therapy programs. This role is accountable for the strategy, governance, and operational oversight of Contract Manufacturing Organizations (CMOs).

The leader will operate as a strategic partner to these organizations, ensuring the highest standards of quality, reliability, and scalability to support clinical development and commercialization.

• External Manufacturing Strategy & Network Leadership
  • Define and execute a phase‑appropriate external manufacturing strategy aligned with Vertex’s pipeline and long‑term commercial vision.
  • Build and operate a resilient, scalable network of CMOs and critical suppliers.
  • Lead governance of contract manufacturing facilities, ensuring strong alignment on performance, quality, and continuous improvement.
  • Establish transparent and effective partnership models with CMOs grounded in trust, accountability, and shared goals.
• CMO Partnership & Oversight
  • Serve as the primary operations leader overseeing manufacturing execution at CMO sites.
  • Drive performance across safety, quality, delivery, and cost through clear KPIs and active engagement.
  • Maintain strong on‑site presence and partnership mindset while holding CMOs accountable to Vertex standards.
  • Identify and proactively mitigate supply and operational risks across the network.
• Tech Transfer & Operational Readiness
  • Partner with MSAT and CMC teams to ensure seamless tech transfer into external facilities.
  • Oversee process validation, comparability, and lifecycle management across multiple sites.
  • Enable readiness for pivotal trials and commercial launch through disciplined planning and execution.
• Quality & Compliance Champion
  • Champion Vertex’s commitment to quality and patients by ensuring full GMP compliance across all CMO operations.
  • Partner closely with Quality to maintain continuous inspection readiness and support regulatory filings and inspections.
  • Ensure robust quality systems, including deviation, change control, and CAPA management across the external network.
• Supply Chain & Integration
  • Integrate CMOs into Vertex’s end‑to‑end supply chain, including raw materials, critical reagents, and logistics.
  • Ensure chain‑of‑identity and chain‑of‑custody integrity for cell therapy products.
  • Build strong, strategic relationships with key suppliers to ensure continuity and performance.
• Financial & Investment Stewardship
  • Oversee budgets, contracts, and capital investments associated with co‑invested facilities.
  • Ensure strong financial governance and return on investment for Vertex‑funded manufacturing assets.
  • Negotiate and manage CMO agreements to align incentives and performance outcomes.
• Cross‑Functional Leadership
  • Partner across Technical Operations, CMC, Regulatory, Quality, and Supply Chain to deliver integrated solutions.
  • Contribute to regulatory submissions (IND, BLA/MAA) and represent Manufacturing Operations in inspections and agency interactions.
• Team Leadership & Culture
  • Build and lead a high‑performing team aligned with Vertex’s values: innovation, integrity, collaboration, and urgency for patients.
  • Foster a culture of ownership, transparency, and continuous improvement.
  • Develop organizational capabilities in external manufacturing, technical oversight, and partnership management.

• Strong understanding of GMP and global regulatory expectations (FDA, EMA, ICH).
• Experience with multi‑site tech transfer, process validation, and lifecycle management.
• Familiarity with advanced therapy supply chains, including traceability and cold‑chain logistics.
• Demonstrated ability to lead through influence in complex, matrixed environments.
• Strong partnership orientation with the ability to build trust while driving accountability.
• Strategic mindset with disciplined operational execution.

• Advanced degree (MS, PhD, or equivalent) in life sciences, engineering, or related field.
• 15+ years of…