Manager II, Enterprise Applications (R&D & GxP Systems)

Job description

About the Role The Manager II, Enterprise Applications (R&D & GxP Systems) is a hands-on role responsible for GxP IT system owner activities across GxP applications, ensuring compliant operations in partnership with the business, Quality, and vendor partners. The role includes configuring and testing the systems, maintaining validation activities, managing system upgrades and releases, and contributing to SOPs, training, and process improvements to keep systems aligned with business needs and regulatory requirements. Let’s talk about some of the key responsibilities of the role: - Act as a subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault platforms and other validated systems supporting Clinical, Regulatory, Quality and other regulated functions - Support the execution of the IT roadmap and system implementations for Clinical, Regulatory and other functional teams performing requirements gathering, risk assessment, impact assessment, solution design, system configurations, testing, and validation activities. - Perform requirement gathering, risk assessment, impact assessment of new implementations and existing systems changes - Collabora...