Vice President, Global Supply & Operations

Role Summary

Vice President, Global Supply & Operations. Lead the strategy and execution for the growth and expansion of global commercial and clinical supply, managing manufacturing, supply chain, and external partnerships with a strong focus on Quality and Compliance.

Responsibilities

• Lead global supply operations, including manufacturing supply for clinical and commercial, external manufacturing, supply chain, and partner management
• Coach, mentor, and develop the team to achieve high performance, quality and safety in biotech GMP manufacturing
• Hold global accountability for strategic supply relationships with commercial partners; collaborate with Alliance Management to ensure uninterrupted supply across markets
• Oversee the global network of CMDOs, improving internal and external partnering with CMOs to increase volume, reduce lead times and costs, and ensure supply during growth
• Work with Quality to ensure routine supply and continuous improvement, including Lean practices, investigations, change controls, and vendor management
• Foster a culture of Quality First and Right First Time, ensuring transparency and collaboration among Quality, Operations, and external partners
• Manage budget and procurement for the Supply Organization; partner with Finance to drive cost savings and standardization
• Collaborate with Regulatory to author regulatory and technical documents for submissions and serve as SME in regulatory interactions
• Other duties as assigned

Qualifications

• BS or BSE in engineering, science, or related field plus 20 years of pharmaceutical/biotech experience, or advanced degree plus 15 years
• Proven GMP pharmaceutical/biotech operations, supply chain and/or technical operations experience; preference for biologics and chemistry backgrounds
• Strong leadership, strategy development/implementation, and change management in pharma/biotech manufacturing
• Experience managing external CDMO partnerships and relationships with multiple customers
• Background in External Manufacturing, Supply Chain, S&OP/MRP, and strategic procurement; experience with supply agreements
• Experience with regulatory filings, change control, regulatory audits, and partner audits
• Track record of operational excellence (visual management, lean, six sigma, etc.)
• Growth mindset and ability to build something new with a talented team
• Willingness to travel domestically and internationally up to 25% (US, Europe, possibly Asia)

Skills

• Strategic planning and execution
• Leadership and team development
• External manufacturing and partner management
• Quality systems and compliance
• Budgeting and procurement optimization
• Regulatory documentation and submissions

Education

• BS/BSE in engineering or sciences; advanced degree preferred

Additional Requirements

• Domestic and international travel as needed