Description

You will manage end-to-end IT programs within a regulated pharma environment.

Responsibilities

• Manage cross-functional IT programs, including MES/LIMS/SAP integrations and orchestration platforms.
• Develop and execute the Computer System Validation (CSV) strategy for complex digital systems.
• Embed GxP requirements (21 CFR Part 11, Annex 11) early into the design and validation lifecycle.
• Ensure platform readiness for regulatory audits, including BLA submissions.
• Drive alignment across scientific, operational, IT, and QA/regulatory teams while managing vendors and scope.

Required Skills

• 7+ years in technical program management, with 17+ years in overall IT experience.
• Deep experience in US pharma, Drug Manufacturing, and Cell Therapy regulations.
• Expertise in GxP regulations and the digital manufacturing system landscape.
• Experience with MES, LIMS, SAP, Scheduler, and Control systems integrations.
• Proficiency with validation frameworks in CAR-T and related cell therapy platforms.
• Familiarity with React JS, Python, Java, SQL, Azure Synapse, Databricks, AWS, Snowflake, RESTful APIs, and Webmethods.

Key Skills

Education

Any Gradute