Director, GMP Systems

Responsibilities

• Operational ownership and execution oversight for business-critical and GMP-impacting systems such as: ERP, Manufacturing Execution & Automation Interfaces, Quality Management Systems (QMS), PLM, Integration & Workflow Platforms, Data & Analytics
• Define and execute the GMP systems strategy aligned with manufacturing scale and commercial readiness 
• Act as the primary systems partner to Manufacturing, Quality, Supply Chain, Engineering, and Finance leadership
• Translate evolving operational needs into practical, compliant system solutions
• Ensure systems support operational execution, compliance, and unit economics  
• Ensure manufacturing execution data, inventory, and quality events flow accurately across systems
• Enable reliable WIP visibility, inventory valuation, and cost capture early to avoid pre-commercial rework
• Support manufacturing readiness without over-engineering controls prematurely
• Partner closely with the Integration Architecture & Data Foundation teams to ensure alignment with enterprise architecture and long-term data strategy.
• Provide business and GMP requirements for integrations across ERP, MES, QMS, and automation platforms.
• Ensure data integrity, traceability, and auditability across manufacturing, quality, and finance processes
• Drive root cause resolution for cross-system issues (data, integration, configuration, or process)
• Establish operational discipline for transports, releases, documentation, and validation support
• Improve business confidence that GMP systems are stable, predictable, and audit-ready
• Provide hands-on leadership to drive execution of critical GMP system initiatives
• Establish clear priorities, milestones, and operational accountability for internal teams and vendors
• Provide day-to-day direction to system integrators and support partners
• Partner with IT leadership and Procurement on vendor strategy and performance management
• Actively intervene to stabilize, course-correct, or accelerate initiatives as business priorities evolve
• Introduce lightweight governance, release discipline, and decision clarity
• Improve confidence from QA, Manufacturing, and leadership that systems “just work” 
• Position IT and systems as business enablers rather than bottlenecks  

Requirements

• Bachelor's in Industrial Engineering, Computer Science, or related field
• 12–15+ years leading enterprise and manufacturing systems in regulated product companies
• Deep experience across ERP, MES, QMS, LIMS and manufacturing data flows
• Proven ability to stabilize and scale underperforming systems
• Strong partnership with Manufacturing, Quality, Supply Chain, and Finance leaders
• Hands-on leadership style, strategic but deeply execution-oriented and comfortable working directly with configurations, data issues, and operational problem resolution
• Experience in highly regulated manufacturing (biotech, medical devices, pharmaceutical, aerospace, or similar)
• Experience building systems before commercial scale
• Track record of translating complex operations into simple, scalable system designs
• Comfort operating in fast-growth environments with ambiguity and evolving requirements  
• Excellent organizational and communication skills
• Self-awareness, integrity, authenticity, and a growth mindset