Position Description:
The Global Quality TechLilly team delivers and maintains applications that support the Global Quality Assurance and Lab organizations at Lilly. This team is part of the broader Manufacturing and Quality (M&Q) TechLilly organization that continues to transform as we look to the digital plant of the future and support manufacturing operational excellence and productivity efforts maximizing the use of technology and analytics.
The Global Quality TechLilly team works in partnership with the Global Quality business central and site representatives to define business needs and provide solutions for Manufacturing Quality. This team is responsible for the support and solution delivery of IT tools that support the Global Quality Assurance business application portfolio, such as Veeva QMS, TrackWise (TW), Quality Intelligence Dashboards, Cold Stream Select, Regulatory Change Management (RCM), and Notification to Management. TrackWise is an industry leading software solution for quality management capabilities. Lilly uses this solution for quality management (deviation, change, observations, etc.), supplier quality management, audit and compliance, and product complaints. The Global Quality business organization is on a transformation path to modernize its business applications by introducing automation/AI, digital technologies, and information management capabilities to be more productive as demand for products grow.
A key role in the Global Quality TechLilly team is the Quality QMS Domain SME position. The Quality QMS Domain SME will have primary responsibility for Tier 3/Tier 4 support of business applications in the Global Quality Assurance portfolio, lead Veeva QMS lifecycle management and other dependent technology LCM and assessments, perform Veeva QMS configurations , manage and drive technical roadmaps aligned with vendor and corporate directions, and assist in operational issue resolution.
Key Objectives/Deliverables:
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Demonstrate functional and technical knowledge of the business area. Understand the portfolio of applications in the Quality space, the business processes these solutions support, key business partners, and the technology infrastructure and architecture that power the solutions.
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Work with the Solutions Architect, and technology vendors to understand strategic roadmaps across the technology stack (servers, databases, reporting solutions, etc). Assist in the planning, implementation, coordination, and communication of lifecycle management activities, and testing of infrastructure changes.
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Serve as an escalation point for the third-party managed service provider to manage problems and issue resolution for the supported solutions in compliance with applicable processes. Work with cross-functional teams to resolve these issues as appropriate.
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Act as the liaison between IDS and the business partner to represent IDS enterprise initiatives and assist in deployments and delivery as appropriate.
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Ensure service providers understand the goal and quality expectations of operational initiatives and provide oversight of these efforts to ensure timely and quality delivery
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Execute reviews of deliverables/documents for key projects
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Ensure application and compliance to Lilly Standards and Quality rules
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Participate in validation of document creation, periodic reviews, and approvals.
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Partner with solution architects to influence and evolve the technology roadmaps and strategic direction to enable M&Q direction.
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Assist or lead activities to stand up future services to meet business demand.
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Influence technical direction of software vendors, and third-party software provider. Ensure third party managed service provider understands technical roadmap.
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Be an active learner. Stay abreast of tools and technologies to influence IT strategy so that it provides best usage opportunities for business.
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Collaborate with Business Process Architects and business partners to understand the requirements, design the solution and perform configurations in the Quality Management System (Veeva QMS).
Basic Requirements:
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At least 4-6 years of work experience in IT, solution development, Trackwise and operations.
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At least 2-3 years experience working with Veeva QMS, Windows, Linux, database technologies, and PL/SQL, GitHub, agile methodologies
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Configure Veeva Vault QMS modules including workflows, document types, lifecycles, fields, and dashboards.
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Manage configuration changes using Agile tools (e.g., JIRA), ensuring traceability and documentation.
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Participate in quarterly Veeva releases, assessing impact and implementing necessary configuration updates.
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Troubleshoot and resolve configuration issues, escalating to Veeva support as needed
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Support integration efforts with other interface systems
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Strong working knowledge with Service Now for incident, problem, and change management
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Demonstrated knowledge of Veeva QMS through certifications or extensive working knowledge.
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Ability to work with business owners to define key business requirements and convert to technical specifications.
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Experience working in regulated environments and with internal systems quality policies and procedures
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Demonstrated ability to establish trusting relationships with business partners
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Demonstrable ability to understand and influence integration points cross-functionally
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Strong written and oral communication.
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Demonstrated interpersonal, self-management, collaboration, project management, and problem-solving skills.
Additional Preferred Requirements:
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Veeva Vault QMS certification.
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Experience in working in Scrum - agile methodologies, coding standards, code reviews, source management (GitHub ), build processes
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Experience with integration tools (e.g., MuleSoft).
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Pharmaceutical or healthcare industry experience
Education Requirements:
Bachelors Degree (or equivalent work experience) in computer science, information technology, or management information systems
Other Information:
Travel to US or other Lilly entities may be required.
After hours support due to manufacturing 24/7 operations may be required.
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