Device and Incoming Testing Lead

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 Device and Incoming Testing lead is primarily responsible for managing device testing and incoming goods testing activities in support of Parental Manufacturing, Device Assembly and Packaging facility in Alzey site.

What tasks await you?

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ensure and enforce compliance with all cGMP procedures, Quality Systems and Good Documentation Practices in Device and Incoming Testing lab.
• Leading the laboratory personnel, give direction and set standards
• Supervise the activities within Device and Incoming Testing labs, including but not limited to:

• Perform laboratory device testing for commercial product;
• Manage incoming goods testing for commercial product;
• Method Transfer/Verification/Validation;
• Participate in flow teams and process teams to ensure smooth collaboration with other departments;
• Change management, Deviation management, Laboratory Investigations;

• Organizing the lab following 5S principle;
• Ensure all the Analysts/Technician within Device and Incoming Testing lab are properly trained.
• Build and maintaining working relationships with Device and Incoming testing labs across Lilly network.
• Oversee QC laboratory equipment setup and qualification, computer system validation and operation in Device and Incoming Testing lab.
• Support regulatory submission and inspections on behalf of Device and Incoming Testing lab., * 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.

• Master Degree, or Bachelor with extensive practical experience in GMP, management science related field is preferred.
• Sufficient qualification for Head of Quality Control
• Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
• Experience with Devices and Incoming goods testing
• Previous experience with Laboratory IT systems such as LIMS and LES
• People management
• Fluent written and oral skills in German and English
• Participated in Regulatory inspections such as EMA, FDA

Additional Skills/Preferences:

• Management experience of third-party laboratories
• Demonstrated knowledge and application of regulations as applicable to the pharmaceutical industry and related quality systems
• Ability to mentor / train others, share learning, * Ability to travel (approximately 10-20 %)

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