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

Eli Lilly and Company • Indianapolis, IN

20h

About The Position

At Lilly, a global healthcare leader headquartered in Indianapolis, Indiana, the company unites caring with discovery to make life better for people worldwide by developing life-changing medicines. The Tech@Lilly organization builds and maintains capabilities using cutting-edge technologies to advance drug discovery and connected clinical trials. The Tech@Lilly Digital Office (DO) and Global Services (GS) team leads digitalization across various enterprise organizations, including Finance, Legal, Ethics & Compliance, Corporate Affairs, and Human Resources, while also delivering best-in-class ERP Solutions. This team leverages technology and analytics to enable enterprise-wide transformations. The Manager - Validation Lead, also referred to as a Senior Consultant - Validation, will be responsible for driving Computer System Validation (CSV) and Computer Software Assurance (CSA) activities. This role ensures compliance, quality, and efficiency across Lilly's computer systems, adhering to Lilly standards and processes. A key aspect of the role is to drive innovation by leveraging AI, digital tools, and automation to simplify and automate CSV processes. The Validation - Center of Excellence (CoE) team, which this role is part of, provides CSV services across all Tech@Lilly business functions, adopting a modern, enterprise-wide approach focused on automation and simplification to ensure consistent, effective, and regulation-aligned validation activities. The DO/GS organization is seeking a motivated candidate passionate about shaping the future of validation through modern approaches like AI and automation, to drive IT quality, compliance, and assurance across Lilly’s mission-critical systems.

Requirements

• In-depth knowledge of regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems like GxP, GAMP 5, FDA 21 CFR Part 820, 21 CFR 210, 21 CFR 211, 21 CFR Part 11, EU Annex 11, ALCOA++ Principles, etc.
• Experience in leading CSV activities across the full system lifecycle (implementation, upgrades, retirement).
• Expertise in documents creation which includes, but not limited to validation plan, System Configuration, System Overview, Security Plan and validation report, etc.
• Hands-on expertise in preparing, reviewing, and approving validation deliverables.
• Strong knowledge of IT system operational compliance processes, including Periodic Reviews and Access Roster Reviews.
• Proven ability to apply risk-based validation approaches in alignment with CSA principles to balance compliance with efficiency.
• Hands-on experience with commonly used industry tools (e.g., Jira, ServiceNow, Veeva).
• Bachelor’s degree in computer science, Information Technology, or a related field.
• Overall 8-10+ years of experience in CSV in pharmaceuticals or life sciences industry.
• Extensive knowledge of GxP, regulatory requirements, and IT system validation processes.
• Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration.
• Strong experience in regulatory compliance, validation processes, risk assessment, IT systems change management, stakeholder collaboration, continuous improvement, project management, and analytical problem-solving.
• Ability to collaborate with technical and non-technical team members.

Nice To Haves

• Excellent interpersonal, analytical, problem solving, and investigative skills.
• Strong communication and collaboration skills.
• Knowledge of Agile principles and frameworks (e.g., Scrum, SAFe), including related tools (such as Jira).
• Demonstrated leadership skills and effectiveness in the areas of influence, team leadership, articulating and taking a position, negotiation, and conflict resolution.

Responsibilities

• 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.
• 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.
• Apply appropriate right sizing method/approach and determine 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.
• Ensure IT system change requests (CR) are executed in compliance with Local/global change control procedures.
• Review CRs and ensure the accuracy and completeness of all change requests.
• Review the impacted validation deliverables.
• Facilitate and support the system custodian/owner and area management to execute access roster and periodic review followed by respective Corrective and Preventive Action (CAPA) closure.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees