Role Summary
The Associate Director of Lab Orchestration you will be responsible for leading designing, integrating, and deploying 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)
- Industry experience implementing Lab orchestration including Scitara, Tetra Science, or any other emerging tools.
Qualifications
- Senior Manager: 8+ years industry experience in Information Systems and Technology or equivalent combination of education and experience. 6 of those years should be in managing employees and budgets, with 5+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment.
- Associate Director: 10+ years industry experience in Information Systems and Technology or equivalent combination of education and experience. 8 of those years should be in managing employees and budgets, with 7+ years of experience in a GMP manufacturing environment and 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