Senior Validation Manager Information Systems - Clinical Data Hub (Telangana)

Role Description: This role is pivotal in shaping and driving the overall validation strategy within the Clinical Design and Analysis technology services group. This role will serve as the subject matter expert for validation processes, ensuring compliance with regulatory standards and best practices throughout the technology lifecycle. By mentoring and guiding validation team members, this individual will foster a culture of quality and continuous improvement as the group builds and transforms technology capabilities that directly impact business outcomes. Their leadership will be instrumental in developing and managing a highly skilled team of validation engineers, empowering them to deliver innovative and robust technology solutions that support biostatistical study design and analysis, while maintaining rigorous validation standards. The ideal candidate must demonstrate deep expertise in validation management, with a proven track record of leadership in technology-driven environments for clinical design and analysis. A passion for fostering innovation and excellence in the biotechnology industry is essential. Collaborate extensively with cross-functional and global teams to ensure seamless integration, operational excellence, and compliance across all deliverables. Candidates must have a strong background in the end-to-end software development lifecycle, particularly within a Scaled Agile Framework, will enable them to champion validation requirements, drive transformation, and support key organizational strategic initiatives. Success in this position requires the ability to cultivate a collaborative environment, uphold high-quality validation standards, and deliver results within a matrixed organizational structure. Roles Responsibilities: - Establish and drive the validation strategy for clinical design and analysis technology services, ensuring alignment with organizational goals and regulatory standards. - Act as the subject matter expert for validation processes, maintaining compliance with regulatory requirements and industry best practices throughout the technology lifecycle. - Oversee and enhance quality assurance activities, ensuring rigorous validation standards are upheld across all technology solutions and deliverables. - Mentor and guide validation team members, fostering a culture of quality, compliance, and continuous improvement within the group. - Lead process improvement initiatives, identifying opportunities to optimize validation procedures and enhance operational efficiency. - Develop and manage a skilled team of validation engineers, empowering them to deliver innovative and robust technology solutions that support biostatistical study design and analysis. - Collaborate with cross-functional and global teams to ensure seamless integration of validation requirements and operational excellence across all deliverables. - Monitor and review validation documentation, audits, and compliance activities, ensuring timely resolution of issues and adherence to regulatory guidelines. - Foster a culture of collaboration, innovation, and continuous improvement. - Attract and recruit top talent as part of an extensive Technology organization to be hired within India. - Collaborate with geographically dispersed teams, including those in the US and other international locations. - Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders - Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through ''test learn'' activities - Ensure communication of key performance metrics and analysis of unmet needs - Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met - Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery - Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the stakeholders feel informed and engaged - Follow global standards and practices. - Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services - Facilitate best practice sharing, ensuring ongoing alignment with the Technology Digital strategy - Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance - Ensure alignment of Technology service plans across organization - Provide education to new partners with regards to IT service offerings - Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy Basic Qualifications and Experience: - Doctorate .