Manager - Validation Lead - Technical Support & Operations - Global Services

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

** About the Tech@Lilly Organization:*
* Tech@Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Tech@Lilly is that we create new possibilities through tech to advance our purpose - creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise.

** About the Business Function:*
* The Tech@Lilly Digital Office (DO) and Global Services (GS) team leads digitalization across organizations spanning the enterprise with Finance, Legal, Ethics & Compliance, Corporate Affairs and Human Resources as well delivers best-in-class ERP Solutions.
This team leverages technology and analytics to enable transformations across the enterprise.

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* Job Title:

Manager - Validation Lead - Technical Support & Operations - Global Services*
* As a Senior Consultant - Validation, you will be responsible for driving Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, ensuring compliance, quality, and efficiency across Lilly computer systems following Lilly standards and processes.

You also will be responsible to drive innovation by leveraging AI, digital tools, and automation to simplify and automate CSV processes.

** About the team:*
* Validation - Center of Excellence (CoE) is a specialized team that provides CSV services across all Tech@Lilly business functions. We adopt a modern, enterprise-wide approach that emphasizes automation and simplification, ensuring validation activities are consistent, effective, and aligned with industry best practices and regulations.

The DO/GS organization is actively looking for a motivated candidate. In this role, you will be responsible for driving IT quality & compliance, and assurance across Lilly's mission-critical systems spanning across various business functions.

Do you have a passion for shaping the future of validation by embracing modern approaches like use of AI and Automation in validation? If so, please apply.

** What you'll be doing:*
* ** Innovation & Automation:*
* + Drive innovation in validation by exploring and leveraging AI, digital tools, and automation technologies to streamline validation documentation, authoring, and review processes.

+ Identify opportunities to simplify CSV/CSA activities through adoption of risk-based approaches, automation frameworks, and smart documentation solutions, reducing effort while maintaining compliance.

+ Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement.

+ Identify and drive  
** continuous improvement, automation, and simplification opportunities
** in validation processes using digital tools or AI-enabled solutions.

** Project Validation:*
* + Lead and coordinate IT system validation by managing the computer system lifecycle from validation/test planning to reporting and ensure compliance with regulatory requirements, Lilly processes and validation standards.

+ Responsible for applying appropriate right sizing method/approach and determining the nature and content of deliverables in scope.

+ Oversee AI/auto generated validation documents by reviewing and updating contents to ensure accuracy, compliance, and alignment with Lilly's quality management system.

+ Review all the project validation deliverables authored by the project team (developer, SME etc.).

+ Escalate and communicate operational issues, critical compliance findings and risks to the Information System Quality (ISQ) organization and other key stakeholders of the system.

+ Educate project team members on Lilly IT processes and methodologies.

+ Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements.

+ Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development.

+ Contribute to internal and external audits, assessments or inspections.

** Change Management:*
* + Ensures IT system change requests (CR) are executed in compliance with Local/global change control procedures.

+ Review CRs and…