Associate Director, Lab Orchestration

Role Summary

The Associate Director of Lab Orchestration leads the design, integration, and deployment of the orchestration layer that connects QC laboratory systems into a cohesive, compliant, and automated ecosystem. This role bridges QC operations, IT/OT, automation, and data governance to enable end-to-end digital QC workflows.

Responsibilities

• Lead the design and implementation of the QC Lab Orchestration Layer, enabling workflow coordination across all Laboratory instruments and middleware.
• Define integration patterns (APIs, event-driven, message queues, file-based where needed).
• Ensure scalability, resilience, and performance of lab integrations.
• Translate QC business processes into orchestrated digital workflows.
• Enable automated sample lifecycle management, test execution, result capture, review, and release.
• Support real-time and near-real-time data flow from lab instruments to enterprise systems.
• Assist in annual IT budgeting, vendor negotiations, and resource allocation.
• Ensure integrations comply with GxP, ALCOA+, 21 CFR Part 11, Annex 11 and data integrity requirements.
• Partner with Quality and CSV teams to support validation strategies (risk-based, CSA where applicable).
• Ensure auditability, traceability, and controlled change management.
• Act as the primary integration point between QC, IT, automation, and external vendors.
• Evaluate vendor platforms and integration tools for orchestration capabilities.
• Lead technical discussions with system integrators and software suppliers.
• Support incident resolution, root cause analysis, and continuous improvement.
• Make decisions on integration patterns and drive a connected lab progression in 2026 and beyond.
• Ensure resiliency is incorporated into our architecture as we move into a connected lab platform.

Skills

• Knowledge of integration technologies: REST APIs, middleware/iPaaS, message brokers, ETL
• Familiarity with orchestration/workflow engines
• Understanding of lab instrument connectivity and data flows
• Experience with cloud and/or hybrid architectures (AWS, Azure, or similar)

Qualifications

• 10+ years of experience in Information Systems and Technology; 8 years in managing employees and budgets; 7+ years in a GMP manufacturing environment; experience in a biotech/pharma environment
• Experience with IT Compliance guidelines including PICS, CFR21 Part 11, Annex 11 and GAMP (preferred)

Education

• BS/BA in Information Technology or related field