Description

Own end-to-end IT program leadership for digital manufacturing systems in US pharma and cell therapy environments, ensuring regulatory compliance and technical integration.

This role is on-site.

Responsibilities

• Manage end-to-end IT programs including MES, LIMS, SAP integrations, scheduler systems, and orchestration platforms.
• Develop and execute Computer System Validation (CSV) strategies, embedding GxP requirements (21 CFR Part 11, Annex 11) early in design.
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams to drive cross-functional alignment.
• Ensure platforms are inspection-ready for BLA submissions and represent Digital in regulatory audits.
• Produce validation artifacts including URS, risk assessments, test protocols, trace matrices, and validation reports.

Required Skills

• 15+ years of IT experience with 7+ years in technical program management.
• Deep experience in US pharma, drug manufacturing, cell therapy, and CAR-T platforms.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, and integration architectures.
• Familiarity with digital validation frameworks in personalized medicine or cell therapy.
• Bachelor's degree in a relevant technical field.

Key Skills

Education

Bachelor's degree