Responsibilities: Supporting and validating regulatory systems like REMS and RIMS. Computer system validation of regulatory systems such as Regulatory Information Management System, REMS, publishing, and eCTD systems used in the pharmaceutical industry. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC application of FDA guidance and industry standards (i.e., GAMP). Strong understanding of 21 CFR Part 11 and a risk-based approach with the ability to guide the project teams. Possess strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner, Business users, SME) and interpret business rules and requirements, documenting them for software development. Expertise in documenting and guiding various SDLC deliverables including Requirements Specification, User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy, Test Planning, Validation Test Summary, and Requirement Trace Matrix. Ability to handle and guide multiple GxP projects. Ability to work with project teams to facilitate interaction between project teams and business stakeholders. Ability to manage, provide guidance, and train the team on policies, end-to-end SDLC processes, procedures, and tools. Train the project team on the relevant procedures associated with different SDLC processes and tools; strong in project management tools like JIRA. Manage project priorities based upon identified risks. Requirements: Ability to troubleshoot and resolve critical and complex tickets. Ability to create root cause analysis for critical issues or faults (hands-on work). Ability to implement necessary preventive measures to reduce future defects. Ability to provide technical assistance to team members in resolving customer issues. Ability to execute continuous improvement activities to improve team performance. J-18808-Ljbffr