Purpose and Scope As a Systems Manager of a series of applications in various areas of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Responsibilities will include a thorough understanding of SLC processes to ensure oversight of the implementation of digital health and eSource systems like IRT/RTSM, eConsent and wearable, with a primary focus on IRT. In addition, this individual will need to be responsible for computer systems validation activities and will have the skill set and experience to be able to make an immediate impact. The manager will contribute to the implementation of requirements and not be limited to vendor collaboration. The development, execution, and continued validation related to the CSV guidelines and procedures will underpin the validation of the facilities’ various software systems and their ongoing maintenance and upgrade. You will be at the forefront of ensuring software is implemented appropriately and ensuring that the highest level of quality goes into the critical tasks of Requirements, Development, Validation and User Acceptance Testing. Responsibilities and Accountabilities Maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Valuable Manufacturing Practice (GMP), Data Integrity (DI), quality and best-practice requirements. Identify and document computer systems that impact GxP and aid in the validation of identified systems. Quickly gain a detailed understanding of current CPI and vendor validation strategies and documentation packages for the validation and UAT of ongoing projects. Hold expertise in validation procedures and performance in line with GAMP5 guidance and how this is applied to highly complex automated systems. Oversee installation and software-testing processes relevant to future projects provided by vendors. Generate, create and write user-acceptance scripts.



Manage the full validation lifecycle of software systems, ensuring that they operate in compliance with GxP/GAMP5 requirements. Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures. Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise. Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions. Quality Assurance: Ensure the highest quality and consistency in the work delivered. Bring in-depth experience operating at an expert level in CSV. Possess significant CSV expertise and experience operating in a GMP environment and developing and implementing validation programs. Required Qualifications IRT/RTSM system experience. The individual must have directly supported this system at the vendor and/or sponsor level. Bachelor’s degree in a relevant field, such as Computer Science or Data Science. Degree-level education, preferably in an IT/Infrastructure Management subject or a Life Science subject, or demonstrable significant GMP/industrial experience, particularly in CSV. Demonstrated experience developing and configuring in the RIM/Quality Docs space using the Veeva Vault platform. Business Process Understanding:



Knowledge of Submissions Management/Quality Document Management business processes and how Vault RIM/QD supports these processes. Strong analytical and problem-solving skills. Ability to work effectively in a team environment. Excellent written and verbal communication skills. Agility and adaptability to changing environments and project scopes. Ability to support technical upgrades six times a year by conducting technical impact assessments, addressing technical issues, supporting environment management and testing, and documenting changes according to the SLC process. Ability to manage user accounts, create roles and support quarterly user-access review requests. Ability to support system deliverables and provide technical feedback during internal and external Veeva Clinical system audits. Ability to work closely with the internal privacy and security team to assess Personal Information requests and act according to applicable privacy laws. Ability to maintain and report issues and communicate effectively to stakeholders during project or enhancement phases, service disruptions and technical upgrades. Preferred Qualifications One to three years of demonstrated experience supporting application validation and UAT. Understanding of how to execute validation-related documents, such as test scripts. Validation Champion: Adherence to Validation and UAT principles. Ability to lead by example regarding validation documents, proficiency, execution and oversight. Must be able to create documents and oversee the process according to established procedures. Technical Proficiency: Strong technical skills to understand how system details relate to validation details. Ability to administer and execute validation activities, support end users, and triage and respond to system issues. System Skills: Office 365, SharePoint, Teams, SQL, and ALM validation software or an equivalent platform.

📌 IRT/RTSM system experience - SA/M Level (India)
🏢 People First Consultants
📍 India