Service Delivery & Validation Lead for QMS presso Lilly

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.

Role: Service Delivery & Validation Lead for QMS

Responsibilities:

The Service Delivery Lead is responsible to design, implement and 
manage the service level management process to deliver the end-to- 
end Technology at Lilly service at a level that supports the business need and 
requirements. The Service Delivery Lead is also responsible for 
developing strong relationships with internal service owners, service 
providers and third-party managers in Technology at Lilly organizations 
regarding the delivery of end-to-end services to support our business 
partners’ and end-users’ service needs.

Key Objectives/Deliverables: 

• Negotiate, agree, and maintain the Service Level Agreements with the Customer. 
• Negotiate, agree, and maintain the Operational Level Agreements with the internal tech providers. 
• Negotiate and agree with both the Customer and Technology at Lilly Provider any Service Level Requirements for any proposed new/developing services. 
• Analyze and review service performance against the Service Level Agreements and Operating Level Agreements. 
• Design and develop the service. 
• Deliver service in line with agreed service levels. 
• Provide accurate updates/changes to the CMDB 
• Set direction regarding new and existing services based on business needs. 
• Provide regular and formal reporting of service level management performance, including deviations from the agreed-upon values, and distribute this report to different levels of the organization. 

-Own end-to-end service delivery for assigned IT/business functions, ensuring SLAs, KPIs, and compliance objectives are consistently met.

-Act as the primary point of contact between business stakeholders, IT teams, and third-party vendors for service-related matters.

-Manage service performance, escalations, and continuous improvement initiatives.

-Oversee incident, problem, and change management processes in line with ITIL best practices.

-Ensure proper documentation and reporting of service metrics, trends, and issues to senior leadership.
• Implement and manage an ongoing service improvement plan and activities. 
• Conduct annual reviews of the service level management process and negotiate and control any amendments necessary.

• Manage relationship with 3rd party vendors and technology partners. 
• Work closely with cross functional teams to ensure seamless integration and delivery.

Develop comprehensive and regulatory-compliant documentation for CSV processes.

• Translate complex technical concepts into clear, accessible language for diverse stakeholders.

• Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.

• Collaborate with cross-functional teams to gather inputs and feedback.

• Draft precise and actionable user stories reflecting functional and compliance requirements.

• Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.

• Document change control processes and prepare CAPA reports

Lead validation activities for systems, applications, and processes within scope, ensuring compliance with GxP standards

-Develop and maintain validation plans, test scripts, and related documentation in accordance with regulatory and internal standards (FDA, EMA, 21 CFR Part 11).

-Coordinate with Quality Assurance, Regulatory Affairs, and business partners to ensure alignment and approval of validation deliverables.

-Perform risk assessments and ensure mitigation plans are implemented for validated systems.

-Drive periodic review and revalidation of systems, maintaining an audit-ready state at all times.
 

Stakeholder & Vendor Management

-Partner with internal teams, external vendors, and service providers to align delivery with business priorities.

-Negotiate service levels and oversee vendor compliance with contractual obligations.

-Communicate effectively with senior stakeholders on project and service status, risks, and improvement plans.

Qualifications:

• Bachelor’s degree in Computer Science, Life Sciences, or related field (Master’s preferred).

• 3-5 years of experience as a technical writer in the pharmaceutical or life sciences domain.

• Strong understanding of CSV principles, GMP guidelines, and regulatory frameworks.

• Excellent writing, editing, and stakeholder engagement skills.

Additional Skills/ Preferences

Bachelor’s degree in Computer Science, Engineering, Computer Information or related field or equivalent work experience 
• 2+ years of Information Technology experience 
• Project and/or service level management experience 
• A demonstrated understanding of the ITIL framework, 
certification is strongly preferred. 
• Experience with vendor management and contract negotiation.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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