Eli Lilly and Company
Associate Director TSMS Sterility Assurance
Eli Lilly and Company, New Bremen, Ohio, United States
Job Title: Associate Director – Sterility Assurance
Location:
Alzey, Rheinland-Pfalz, 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 professionals who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide. Key Objectives/Deliverables:
The Associate Director Sterility Assurance develops and maintains up-to-date technical/scientific knowledge and expertise in sterility assurance (QA/QC, microbiology, environmental monitoring, TS/MS, engineering, sterile manufacturing, etc.) Is responsible for technical investigations or evaluations, and sterility assurance improvement projects Evaluates, suggests, and makes decisions on technical solutions during project activities or change controls, including approving or rejecting them Defines, develops, evaluates, and validates on-site sterility assurance strategies to ensure compliance with current regulations and Lilly Global Quality Policies and Common Quality Practices Reports sterility assurance quality issues and inspection risks to site leadership as part of site reviews and in global forums as appropriate. Actively participates in regulatory inspections, internal audits, or global audits as a key contact for sterility assurance. Serves as a primary contact for all matters related to sterility assurance during Health Authority inspections, internal audits and as needed external audits of business partners/suppliers/etc. Develops and Implements EM sampling strategy and execution Responsible for site CCS (Contamination Control Strategy) How do you convince us?
Bachelor’s degree in science, Engineering, Management, or a related field. A Master's degree in any of these disciplines is desirable. Proven 7+ years of experience working in the medical device industry, with preferred experience in assembly and packaging and a minimum of 3 years of leadership experience. Possess a solid understanding of the basic requirements of regulatory agencies such as the FDA and EMEA. Demonstrate strong leadership, work well within a team, and are passionate about people development Adept at problem-solving and eager to lead your team, equally passionate about the opportunity to be part of the site start-up. Adaptability and passion are critical. Your leadership will inspire your team and foster growth opportunities at the site. You are ready to take on new challenges and drive success. Open to international travel, proficient in German and English, and willing to work at the Alzey site. 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 for further assistance. 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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Alzey, Rheinland-Pfalz, 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 professionals who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide. Key Objectives/Deliverables:
The Associate Director Sterility Assurance develops and maintains up-to-date technical/scientific knowledge and expertise in sterility assurance (QA/QC, microbiology, environmental monitoring, TS/MS, engineering, sterile manufacturing, etc.) Is responsible for technical investigations or evaluations, and sterility assurance improvement projects Evaluates, suggests, and makes decisions on technical solutions during project activities or change controls, including approving or rejecting them Defines, develops, evaluates, and validates on-site sterility assurance strategies to ensure compliance with current regulations and Lilly Global Quality Policies and Common Quality Practices Reports sterility assurance quality issues and inspection risks to site leadership as part of site reviews and in global forums as appropriate. Actively participates in regulatory inspections, internal audits, or global audits as a key contact for sterility assurance. Serves as a primary contact for all matters related to sterility assurance during Health Authority inspections, internal audits and as needed external audits of business partners/suppliers/etc. Develops and Implements EM sampling strategy and execution Responsible for site CCS (Contamination Control Strategy) How do you convince us?
Bachelor’s degree in science, Engineering, Management, or a related field. A Master's degree in any of these disciplines is desirable. Proven 7+ years of experience working in the medical device industry, with preferred experience in assembly and packaging and a minimum of 3 years of leadership experience. Possess a solid understanding of the basic requirements of regulatory agencies such as the FDA and EMEA. Demonstrate strong leadership, work well within a team, and are passionate about people development Adept at problem-solving and eager to lead your team, equally passionate about the opportunity to be part of the site start-up. Adaptability and passion are critical. Your leadership will inspire your team and foster growth opportunities at the site. You are ready to take on new challenges and drive success. Open to international travel, proficient in German and English, and willing to work at the Alzey site. 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 for further assistance. 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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