Description

You will manage complex IT programs within regulated pharmaceutical and cell therapy environments.

Responsibilities

• Manage end-to-end IT programs, including MES/LIMS/SAP integrations and orchestration platforms.
• Develop and execute Computer System Validation (CSV) strategy across digital systems.
• Ensure platforms meet GxP requirements (21 CFR Part 11, Annex 11) early in the design phase.
• Represent Digital in regulatory audits and ensure systems are inspection-ready for submissions.
• Drive cross-functional alignment between scientific, operational, IT, and QA/regulatory teams.

Required Skills

• 7+ years of experience in technical program management within US pharma or cell therapy.
• 15+ years of overall IT experience.
• Deep knowledge of GxP regulations and the validation lifecycle.
• Experience with MES, LIMS, SAP, and control systems integration architectures.
• Proficiency in SQL, Python, and R for data handling.
• Experience with AWS and Azure Synapse cloud ecosystems.
• Familiarity with RESTful APIs and Camunda BPM.
• Bachelor's degree required.

Key Skills

Education

Bachelor's degree