Senior Assistant, Quality Assurance – Document Control (m/w/d)

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:

Senior Assistant, Quality Assurance – Document Control (m/w/d)

What tasks await you?

The Senior Assistant, Quality Assurance – Document Control, is responsible for electronic documentation and records management oversight at the Alzey site. This role is responsible for execution, maintenance, and administration of document management systems. The Document Controller will aid in initial program startup and routine operation of the site, as well as support site inspection readiness and execution. 

Key Objectives/Deliverables:

• Maintain GMP Library document inventory control through the Lilly Record Manager (LRM) system, as required.

• Create and run reports in LRM to check inventory in the system on a semi-annual basis as a Record Administrator (RA).

• Maintain Document Controller role for all documents and records maintained in Veeva Quality Docs Electronic Document Management System (EDMS). 

• Ensure compliance to global and local Documentation and Records Management requirements. 

• Create, update, and route documents for review and approval in the EDMS.  

• Support other functions with the creation, update, routing, review and approval of electronic documents by appropriate Lilly personnel. 

• Manage and monitor assigned Veeva Vault QualityDocs workflows. 

• Meet with Lilly internal personnel to review documents and assign Veeva Quality Docs meta data when adding documents into the Veeva Quality Docs EDMS. 

• Manage Retention of GMP Related Records in accordance with Document Type and Record Class Codes (RCC).  This includes shipment of GMP records to External storage location for long term retention as necessary. 

• Manage controlled print of GMP forms and facilitate reconciliation process for executable records. 

• Support external and internal audits through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or Lilly internal auditing and compliance groups. 

• Support Site Self Inspections associated with Document Control and the Veeva Vault Q Docs Electronic Data Management System (EDMS). 

• Monitor and ensure that document periodic reviews are performed within Veeva Vault QualityDocs according to Lilly standards. 

• Follow up with document owners to ensure review and updating on a timely basis. 

• Work closely with Quality, Learning and Development, and other Lilly functions to ensure their document needs are captured as required. 

How do you convince us?

• High school diploma or equivalent

• Minimum 3 years in the pharmaceutical industry with previous document management experience.

• On-site presence required.

• English and German knowledge fluent

Additional Skills/Preferences:

• Experience with Microsoft Office (e.g., Outlook, Word, Excel). 

• Previous experience in records management, data entry, or similar experience. 

• Demonstrated ability to work successfully in a team environment. 

• Demonstrated Project Management skills. 

• Strong written and verbal communication skills. 

• Strong ability to solve problems and make decisions. 

• Experience with documentation in a GMP environment and electronic tracking of documentation. 

• Experience in quality systems such as Veeva Vault QualityDocs.

Additional Information:

• Primary location is Alzey, Germany.

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.