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.
At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."
As the Quality Assurance/Quality Control IT System, you will be responsible for leading the successful implementation of LABS solution across our organization. You will leverage your deep knowledge of Labs, collaborate with cross-functional and global teams, and design tailored solutions to optimize our Laboratories processes, enhance compliance and efficiency, and drive overall operational excellence for the site.
Key Objectives/Deliverables:
- 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 LABS solutions align with organizational goals and industry best practices.
- Develop and execute comprehensive project plans, including timelines, resource allocation, and risk mitigation strategies, to ensure successful implementation within budget and schedule constraints.
- Build strong relationships with key stakeholders, including senior management, department functional leaders, and end-users, to understand their requirements, gain buy-in, and ensure seamless adoption of the LABS system.
- Work closely with global IT, operations, technical services and quality teams to integrate the LABS solution with existing systems and processes, ensuring data integrity, system reliability, and scalability.
- Develop training programs and materials to educate end-users on the effective utilization of the LABS system. Create comprehensive documentation, including user guides, standard operating procedures, and technical specifications.
- Stay abreast of industry trends, emerging technologies, and best practices related to LABS implementation. Identify opportunities for process improvements, system enhancements, and operational optimizations.
- Lead ongoing support, troubleshooting, and maintenance of the LABS system, ensuring the highest level of system availability and performance.
- Bridge the gap between technical expertise and business requirements, translating complex concepts into understandable terms for diverse audiences.
- Define and lead the governance of the execution of the LABS agenda including items like communication plan to stakeholders, prioritization, scorecard, promotion of program to the global organization and site employees, etc.
- Ensure LABS system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly corporate policy and procedures, and local procedures to maintain product quality and safety.
- Develop and execute comprehensive testing strategies, including unit testing, system integration testing, and user acceptance testing, to validate the functionality, performance, and reliability of the LABS system.
- LABS System Custodian ensuring the compliant and reliable operation of the LABS system, maintaining data integrity, managing system configurations, supporting validation activities, and driving continuous improvement in line with GMP requirements.
- Collaborate with internal and external auditors to facilitate LABS audits and inspections, addressing any findings promptly.
Basic Qualifications:
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
- Minimum of 5+ years of LABS implementation experience working in GMP regulated industry.
- Experience with IT audits, compliance assessments, and remediation activities, including addressing findings and implementing corrective actions.
- Deep knowledge and experience with LABS platforms,
- Experience leading end-to-end LABS implementation projects in GMP environment, from requirements gathering to deployment, while managing resources, timelines, and risks.
- Proficient in project management methodologies, such as Agile or Waterfall, to effectively plan, execute, and deliver LABS implementation projects.
- Expertise in integrating LABS systems with other enterprise systems, such as ERP (Enterprise Resource Planning) and MES (Manufacturing Execution System), to ensure seamless data flow and system interoperability.
- Knowledge of data management principles, including data validation, transformation, migration, and reporting.
- Strong understanding of Quality control processes in the pharmaceutical industry.
- Strong change management skills to drive organizational change, manage resistance, and ensure user adoption of new LABS systems and processes.
- Excellent communication and interpersonal skills to effectively engage and collaborate with stakeholders at all levels, including senior management, department heads, and end-users.
- Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
- Strong analytical and problem-solving skills to identify and resolve technical issues related to LABS systems, configurations, or integrations.
- Ability to troubleshoot system performance, data integrity, or connectivity problems, working collaboratively with IT teams and vendors to implement solutions.
- Proven leadership abilities to lead cross-functional teams, assign tasks, manage priorities, and foster a collaborative and productive work environment.
- Understanding of cybersecurity concepts and best practices related to LABS technologies.
· Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
Additional Skills/Preferences:
- Master’s degree in Computer Science, Information Technology, Business Administration, or a related field is preferred.
- Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
- Proficiency in German and strong English language skills
- On-site presence required
What can you look forward to with us?
- Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
- Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
- Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
- Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Lilly University."
- Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.
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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