Computer System Quality Assurance /Data Integrity Representative (m/w/d) bei Lilly

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."

Join our Lilly team in Alzey and start as soon as possible as:

Computer System Quality Assurance /Data Integrity Representative (m/w/d)

What tasks await you?

Function as a CSQA working with Global Facility Delivery, Lilly project staff, Global CSQA, and selected External Contracting firms to complete the detailed design of the assigned areas employing Quality by Design (QbD) and Quality Risk Management (QRM) principals and ensuring the integration of Global Quality System requirements into the design. Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule and consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase. Provide technical and quality review and approval of project computer system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures

Key Objectives / Deliverables:

• Assure the computer systems (e.g. IT systems, Lab Automation, M&Q Automation) in Lilly Alzey site are developed, deployed and maintained according to Lilly standards and Quality Procedures conforming to regulatory expectations. Provide quality oversight throughout the whole lifecycle of computer systems to ensure the validation state.

• Review and approve IT /Automation systems related documents according to Risk Evaluation and Responsibilities for Computerized Systems

• Manage CSQA priorities, schedules to assure timely delivery of CSQA and Lilly – Alzey objectives.

• Assist Data Integrity (DI) related projects for the Alzey site

• Participate in Audit Trail Review of Computer Systems and adhere to Global Lilly Standards

• Participate in DI Assessment of Computer Systems, Interfaces, Processes to identify any potential data vulnerabilities in the design of the systems

• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff

• Foster a strong quality culture including maintaining open communications, promoting teamwork and employee participation in the work group.

• Establish partnership with the Technology Team, system owners, business owners and provide rationale with data/ Lilly guidance / priorities, etc.

• Resolve or escalate any compliance issues to the project, site, and Quality Management

• Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site Computer Systems

• Participate in self-led inspections and provide support during internal/external regulatory inspections

• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents)

How do you convince us?

• Bachelor's degree in engineering or computers preferred or Science related field

• At least 5 years working in the pharmaceutical or medical device industry in QA or CSV roles

• Previous CSQA / CSV experience

• Proficiency with GMP computer systems validation including regulations governing them

• Demonstrated strong oral and written communication and interpersonal interaction skills

• Demonstrated strong technical writing skills

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

• Recognize and escalates potential long-term risk for project and Site schedule.

• English knowledge fluent

• Proficiency in German is a plus

Additional Skills/ Preferences

• Previous facility or area start up experience

• Previous experience with SAP or other inventory management systems CQA certification from the American Society for Quality (ASQ)

Additional Information

• The position is for the Alzey site and during the project phase will allow for a flexible working environment

• Position may require a short duration assignment of 1-3 weeks in another site to establish specific CSQA / Data Integrity knowledge and establish global contacts

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 "Corporate 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.

Have we piqued your interest? Then please apply online with your complete application documents through our applicant portal.

We look forward to your application!

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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