Senior Associate, Quality Assurance – Data Steward (m/w/d)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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:

Senior Associate, Quality Assurance – Data Steward (m/w/d)

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Data Steward represents Quality Assurance on projects, including six sigma. Finally, the QA Data Steward is responsible for activities that include SAP master data management, change management, deviation management, procedure management, management of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.

What tasks await you?

• Support the site in the development and execution of the site readiness plan with focus on supporting startup of new systems and oversight of the establishment of site master data.

• Support the implementation, validation and maintenance of the software based computerized quality systems for the site

• Serve as the Power User for IT systems supported by QA including LIMS, Manufacturing Execution System (PharmaSuite), SAP, TrackWise, Veeva Suite.

• Create and manage quality master data in SAP including q-info records and inspection plans for materials.

• Protect the integrity and accuracy of data to be entered into the quality systems, perform data identification and reviews as required.

• Lead, Mentor and Coach site personnel on the quality systems.

• Responsible for site compliance area documents, including specifications and procedures.

• Partners and builds relationships with Global Quality Network and Global IT team members.

• Provides oversight and supports continuous improvement of quality systems.

• Support onboarding of new materials in TrackWise.

• Effectively review/approve GMP documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications, change controls).

• Participate in self-led inspections and/or provide support during internal inspections.

• Support regulatory inspection activities as needed by providing documentation and SME support.

How do you convince us?

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.

• Minimum 5 years in the pharmaceutical industry with specific data stewardship experience.

• Fluent in English and German.

• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.

• Previous experience in GMP production environments.

• Proficiency with applicable computer systems including SAP, Trackwise, and Veeva

• Demonstrated strong oral and written communication skills

• Demonstrated interpersonal skills and the ability to work as a team

• Ability to influence internally and externally.

• Root cause analysis/troubleshooting skills.

• Demonstrated attention to detail and ability to maintain quality systems.

• Proven ability to work independently or as part of a Team to resolve an issue.

• Technical Writing and Communication Skills.

• Previous regulatory inspection readiness and inspection execution experience.

• Knowledge of operations business processes such as batch disposition, materials management, laboratory specification/method management.

• Previous experience with SAP or other inventory management systems.

• Previous experience with device and parenteral product materials

Additional Information:

• Primary location is Alzey, Germany

• Ability to travel (approximately 10%)

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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