Quality Qms Domain Sme

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.

**Position Description**:
**Key Objectives/Deliverables**:

- 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.
- 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.
- Act as the liaison between IDS and the business partner to represent IDS enterprise initiatives and assist in deployments and delivery as appropriate.
- Ensure service providers understand the goal and quality expectations of operational initiatives and provide oversight of these efforts to ensure timely and quality delivery
- Execute reviews of deliverables/documents for key projects
- Participate in validation of document creation, periodic reviews, and approvals.
- Partner with solution architects to influence and evolve the technology roadmaps and strategic direction to enable M&Q direction.
- Assist or lead activities to stand up future services to meet business demand.
- Influence technical direction of software vendors, and third-party software provider. Ensure third party managed service provider understands technical roadmap.
- Be an active learner. Stay abreast of tools and technologies to influence IT strategy so that it provides best usage opportunities for business.
- 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**:

- At least 4-6 years of work experience in IT, solution development, Trackwise and operations.
- At least 2-3 years' experience working with Veeva QMS, Windows, Linux, database technologies, and PL/SQL, GitHub, agile methodologies
- Configure Veeva Vault QMS modules including workflows, document types, lifecycles, fields, and dashboards.
- Manage configuration changes using Agile tools (e.g., JIRA), ensuring traceability and documentation.
- Participate in quarterly Veeva releases, assessing impact and implementing necessary configuration updates.
- Troubleshoot and resolve configuration issues, escalating to Veeva support as needed
- Support integration efforts with other interface systems
- Strong working knowledge with Service Now for incident, problem, and change management
- Demonstrated knowledge of Veeva QMS through certifications or extensive working knowledge.
- Ability to work with business owners to define key business requirements and convert to technical specifications.
- Experience working in regulated environments and with internal systems quality policies and procedures
- Demonstrated ability to establish trusting relationships with business partners
- Demonstrable ability to understand and influence integration points cross-functionally
- Strong written and oral communication.
- Demonstrated interpersonal, self-management, collaboration, project management, and problem-solving skills.

**Additional Preferred Requirements**:

- Veeva Vault QMS certification.
- Experience in working in Scrum - agile methodologies, coding standards, code reviews, source management (GitHub), build processes
- Experience with integration tools (e.g., MuleSoft).
- Pharmaceutical or healthcare industry experience

**Education Requirements**:
Bachelor's 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.

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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