Global leader in TIL cell therapy development and delivery for solid tumors.
First FDA-approved one-time treatment for advanced melanoma with over 95 authorized treatment centers.
End-to-end cell therapy company with centralized U.S. manufacturing serving thousands of patients worldwide.

Role Overview:

Partners with R&D and Commercial stakeholders to select and implement systems for clinical, regulatory, and commercial operations.
Leads transition of regulatory information management from Veeva Vault RIM to Generis CARA.
Serves as system owner and administrator for a portfolio of validated R&D and Commercial applications.

Key Responsibilities:

Manage system implementations, migrations, and vendor relationships.
Ensure systems comply with FDA 21 CFR Part 11, GxP, and data integrity requirements.
Author and maintain system documentation such as validation deliverables and SOPs.

Qualifications:

Bachelor's degree in Information Systems, Computer Science, Life Sciences, or equivalent.
10+ years of IT experience in biotech/pharma, with 5+ years supporting R&D or clinical/regulatory systems.
Hands-on experience with Veeva Vault, Argus Safety, or comparable regulated R&D applications.

Iovance Biotherapeutics

Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. It is an end-to-end cell therapy company with centralized U.S. manufacturing serving thousands of patients worldwide, fostering a diverse and inclusive culture.

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