Quality Assurance/Quality Control IT System Analyst at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Deep knowledge of LABS systems
Experience in leading end-to-end implementation processes, including requirements gathering, solution design, configuration, testing, deployment, and support
Strong collaboration skills with cross-functional, global teams, stakeholders, senior management, department leaders, and end-users
Ability to analyze business needs, define functional requirements, and align solutions with organizational goals and industry best practices
Project management expertise, including developing project plans, timelines, resource allocation, and risk mitigation
Knowledge of integrating systems with existing IT, operations, technical services, and quality processes, ensuring data integrity, reliability, and scalability
Experience in developing training programs, materials, user guides, SOPs, and technical documentation
Awareness of industry trends, emerging technologies, and best practices in LABS implementation
Skills in troubleshooting, maintenance, and ensuring system availability and performance
Ability to bridge technical expertise and business requirements, translating complex concepts for diverse audiences
Expertise in governance, including communication plans, prioritization, scorecards, and program promotion
Knowledge of industry regulations (e.g., FDA guidelines, GMP), Lilly corporate policies, and local procedures
Experience in developing and executing testing strategies (unit, integration, UAT)

Responsibilities

Take ownership of the end-to-end LABS implementation process, including requirements gathering, solution design, configuration, testing, deployment, and ongoing support
Collaborate with stakeholders to analyze business needs, define functional requirements, and ensure alignment with goals and best practices
Develop and execute comprehensive project plans, including timelines, resources, and risk mitigation, within budget and schedule
Build relationships with stakeholders to understand requirements, gain buy-in, and ensure seamless adoption
Work with global IT, operations, technical services, and quality teams to integrate LABS with existing systems
Develop training programs and materials; create documentation (user guides, SOPs, technical specs)
Stay abreast of trends and identify opportunities for improvements, enhancements, and optimizations
Lead ongoing support, troubleshooting, and maintenance for system availability and performance
Bridge technical and business gaps, translating concepts for diverse audiences
Define and lead governance of LABS execution (communication, prioritization, scorecard, promotion)
Ensure compliance with regulations (FDA, GMP), corporate policies, and local procedures
Develop and execute testing strategies (unit, integration, UAT) to validate functionality, performance, and reliability
Serve as LABS System Custodian, ensuring compliant and reliable operation

Skills

LABS

Quality Assurance

Quality Control

IT Systems

Requirements Gathering

Solution Design

Configuration

Testing

Deployment

Project Management

Stakeholder Collaboration

Business Analysis

Functional Requirements

GMP Compliance

Laboratory Processes

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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