Executive Director, Manufacturing Operations – T1D

Job Description General Summary

At Vertex, we are 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.

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 biopharmaceutical manufacturing…