Qureos Mentor

Eli Lilly and Company

<div>
 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&rsquo;re looking for people who are determined to make life better for people around the world.
 
 
 The purpose of the Associate/Senior Associate/Principal Associate &ndash; MQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and Clinical Development.
 
 
 
 Primary Responsibilities
 
 
 
 
 Implement and Manage Quality Systems
 
 
 
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 Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.
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 Recommends new quality system documents or changes to existing quality system documents where applicable.
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 Advise on appropriate training for implementation and documentation.
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 Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
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 Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
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 Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
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 Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
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 Complete self-inspections and drive improvements that are meaningful and actionable
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 Ensure local implementation of the quality systems as necessary.
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 Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
 
 
 
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 Provide Quality Oversight for the Clinical Development
 
 
 business area
 
 
 
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 Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.
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 Communicates and escalates to management as appropriate.
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 Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.
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 Provide updates to quality and business owners.
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 Seek and implement simplification and process improvement.
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 Coordinate quality improvement initiatives.
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 Review metrics and trending to improve processes and compliance, as assigned. Compile compliance metrics and maintain metrics process (for example, periodic report metrics).
 
 
 
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 Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).
 
 
 Monitor completion of deviations, change controls, CAPA, audit responses.
 
 
 
 Audits and Inspections
 
 
 
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 Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
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 Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
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 Ensure completion of audit corrective action plans and timely resolution.
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 Leads and/or supports readiness activities in collaboration with business partners.
 
 
 
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 Partnership with the Clinical Development
 
 
 business area
 
 
 
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 Functions as the initial point of consultation for the Clinical Development business area on quality related questions.
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 Partners with the Clinical Development business area to strengthen and ensure appropriate quality controls are in place.
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 Shares key learning to drive simplification and replicate best practices
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 Collaborates with other quality groups as appropriate and develops quality network.
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 Establishes good working relationships with the Clinical Development business area.
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 Actively participates in team, business and quality related meetings.
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 Supports issue resolution including escalation.
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 Utilize a risk-based approach in guiding business areas.
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 Support key projects as assigned.
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 Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
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 Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
 
 
 
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 Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.
 
 
 Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.
 
 
 
 Minimum Qualification Requirements
 
 
 
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 Bachelor&rsquo;s Degree in a science/technology/health care related field or equivalent work experience
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 Demonstrated ability to apply quality systems within a regulated work environment
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 Effective project and time management skills
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 Demonstrated ability to communicate effectively, both written and verbal, and to influence others
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 Demonstrated ability to prioritize and handle multiple concurrent tasks
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 Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
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 Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
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 Effective organization/self-management skills
 
 
 
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 Other Information/Additional Preferences
 
 
 
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 Experience in a quality control/quality assurance role
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 Experience in clinical trial management.
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 Knowledge of quality systems
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 Ability to work independently and as part of a team
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 Demonstrated ability to work in a global environment
 
 
 
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 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.
 
 
 #WeAreLilly
</div>

Sr. Associate Manager / Lead, GMQO

<div>
 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&rsquo;re looking for people who are determined to make life better for people around the world.
 
 
 
 Software Engineer
 
 
 
 
 About The Technology Organization
 
 
 
 Technology at Lilly builds and maintains capabilities using pioneering technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose &ndash; 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 solutions in every area of our business.
 
 
 
 About The Business Function
 
 
 
 The Software Product Engineering (SPE) team is a specialised engineering group that delivers strategic solutions and differentiated capabilities. We take a forward-thinking approach, focusing on an enterprise platform and product mindset, ensuring that the solutions we build can be leveraged across Technology teams for broader impact and efficiency.
 
 
 
 Job Title: Software Engineer
 
 
 
 
 Role Summary
 
 
 
 As a Backend Software Engineer, you will develop and maintain reliable server-side applications and APIs, ensuring performance, security, and compliance with industry standards. You will collaborate with cross-functional teams to deliver scalable solutions that support business-critical applications.
 
 
 
 What You&rsquo;ll Be Doing
 
 
 
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 Develop and maintain reliable server-side applications using Node.js and Express.js.
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 Build and maintain RESTful APIs to support frontend systems and external service integrations.
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 Work with PostgreSQL databases using ORM tools such as Sequelize or Knex.js.
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 Apply appropriate caching strategies and integrate distributed components (e.g., Redis, CDNs, message queues) to improve system performance.
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 Handle file uploads and processing using tools like Multer or CSV Parse.
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 Implement secure authentication using frameworks such as Azure MSAL Node, JWT, or express-session.
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 Optimise backend services for performance and security.
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 Collaborate with frontend developers to ensure smooth integration and API consumption.
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 Support CI/CD pipelines using tools like GitHub Actions or Docker.
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 Assist with infrastructure management on AWS (e.g., ECS Fargate, S3, RDS PostgreSQL, Secrets Manager, CloudFormation).
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 Participate in code reviews and contribute to backend best practices.
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 Implement security best practices (e.g., Helmet, CORS, SSL/TLS, rate limiting).
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 Ensure backend solutions comply with healthcare regulations (e.g., HIPAA, GDPR).
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 Maintain data privacy and protection protocols throughout the software development lifecycle.
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 Leverage AI tools (e.g., GitHub Copilot) to improve development workflows and code quality.
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 Work collaboratively with team members on responsible and secure use of AI in development.
 
 
 
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 How You Will Succeed
 
 
 
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 Apply good system design practices to build modular and reliable backend solutions.
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 Participate in code reviews, refactoring, and continuous improvement.
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 Communicate effectively and work collaboratively across backend, frontend, DevOps, and product teams.
 
 
 
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 What You Should Bring
 
 
 
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 2&ndash;4 years of experience in backend development using Node.js and Express.js.
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 Understanding of API design (REST; GraphQL is a plus) and real-time data flow.
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 Experience working with PostgreSQL and ORM tools (Sequelize or Knex.js).
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 Exposure to cloud infrastructure (preferably AWS), CI/CD pipelines, and containerisation (Docker).
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 Awareness of caching strategies and distributed system components (e.g., Redis, CDN, message queues) to support scalable and maintainable solutions.
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 Understanding of secure authentication and authorisation frameworks.
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 Awareness of security best practices and compliance in regulated environments.
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 Bachelor&rsquo;s degree in computer science, Computer Engineering, or a related field.
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 Effective verbal and written communication skills.
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 Willingness to participate in code reviews, refactoring, and continuous improvement.
 
 
 
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 Basic Qualifications And Experience Requirement
 
 
 
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 2&ndash;4 years of hands-on experience in backend development.
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 Bachelor&rsquo;s degree in computer science, Computer Engineering, or a related field.
 
 
 
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 Additional Skills/Preferences
 
 
 
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 Knowledge of accessibility best practices and WCAG standards.
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 Having AWS and Kubernetes certifications is a significant advantage and will be highly valued for this role.
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 Experience in regulated industries (e.g., Life Sciences) is a bonus but not required.
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 Contributions to open-source projects or developer communities.
 
 
 
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 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.
 
 
 #WeAreLilly
</div>

Software Engineer

Join Eli Lilly and Company and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Eli Lilly and Company

ABOUT_COMPANY

Sr. Associate Manager / Lead, GMQO

Software Engineer