The Business Applications Manager - GxP Application Management (Contract) acts as the liaison between Pharmacovigilance, Quality, Regulatory and other business users, software support vendors, and internal IT teams. This profile focuses on end-to-end ownership, implementation, enhancement, integration, validation coordination and support of GxP and business-critical applications such as Argus, Ennov, Axway, Quality applications and other relevant platforms, ensuring compliant, stable and efficient operations.

Education/Experience Required

- B.S. in Information Technology, Computer Science, Engineering, Life Sciences or equivalent

- 8-12 years of relevant experience in GxP application management, IT project delivery, enterprise application support or business application ownership

- Experience in Pharmaceutical, Life Sciences, Pharmacovigilance, Quality or Medical Device industry required





- Hands-on experience with GxP applications such as Argus, Ennov, Axway, Quality applications or similar regulated business applications preferred

- Robust understanding of GxP compliance, computer system validation lifecycle, GAMP 5 principles, data integrity expectations and change control processes

- Experience coordinating with business users, CSV/Validation, Quality, IT Security, Infrastructure, SAP, vendors and global cross-functional teams

- Experience in application support models, vendor management, incident/change/release management and implementation of application enhancements

- Ability to support UAT, validation testing, training material preparation, user training and post-implementation support

📌 GxP Business Application Manager (Kurla)
🏢 iTech US
📍 Kurla