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, 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.Position Overview: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 control leaders to support our growth in Kenosha County, Wisconsin. This is a unique opportunity to deliver on new manufacturing investments and new state of the art QC laboratories.The Associate Director, Quality Control (QC) – Microbiology, is responsible for leading the site QC organization, specifically operations relating to Microbiological Testing and Environmental Monitoring. This role will partner with the Senior Director, Quality Control, to lead the overall Quality Control department with a focus on developing mature laboratory operations with a strong quality and safety culture. This leader will implement the Quality Management System in the laboratory and ensure that appropriate capabilities and business processes are developed and sustained. The leader will also partner with engineering to deliver a state-of-the-art laboratory utilizing the latest in automation to further the analytical capabilities of the organization.  This position involves working cross functionally within the site and across the network to develop the functional capabilities needed to support the mission of the site. This includes assurance that laboratory results are timely, reliable, and in accordance with regulatory requirements.The individual in this role must have expertise in Quality Control operations, specifically microbiological and environmental monitoring test methods, and quality systems. The QC leader must also have demonstrated ability to develop and lead teams and influence across networks and with global organizations.Responsibilities:<ul><li>Work with cross-functional and global teams to drive delivery of full laboratory operations, including method, utilities, and equipment implementation.</li><li>Work with the Senior Director – QC and the Site Quality Leader to support laboratory business and strategic planning to align with company, business unit and site goals.</li><li>Lead talent acquisition initiatives for the laboratory to build a diverse team to support completion of laboratory implementation as well as sustained laboratory growth.</li><li>Ensure all aspects of safety are incorporated into the lab and maintaining a safe work environment, including supporting all HSE Corporate and Site Goals.</li><li>Establish a laboratory operation compliant with Lilly Global Quality Standards and regulatory requirements through development of effective processes and through maintenance and monitoring of laboratory key performance indicators.</li><li>Establish and maintain cross-site network to support alignment of site laboratory practices with global best practices. </li><li>Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation.</li><li>Manage laboratory costs, including management of purchase orders, approval of invoices and oversight of laboratory contractors and third-party entities.</li><li>Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.</li><li>Lead, coach, and aid in personnel development and performance management.</li><li>Ensure a fair and equitable work environment.</li><li>Lead and oversee regulatory and audit/inspection commitments, including annual product reviews, management reviews and audit/inspection responses.</li><li>Interact with regulatory agencies during inspections regarding cGMP issues.</li><li>Ensure that there are adequate numbers of qualified personnel to perform testing.</li><li>Ensure that people in responsible positions are qualified and have adequate authority to carry out their responsibilities.</li></ul>Basic Qualifications:<ul><li>Bachelor of Science degree or equivalent in a scientific field (preferably microbiology)</li><li>Minimum of 5 years’ GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer</li><li>Minimum of 5 years’ leadership experience (ideally in Quality Control) supporting parenteral operations</li><li>Supporting regulatory inspections</li><li>Fluent in English</li><li>On-site presence required</li></ul>Additional Skills/Preferences:<ul><li>Extensive knowledge and experience with compliance, compendial and regulatory requirements.</li><li>Experience with regulatory inspections and audit readiness, including coaching of personnel and back room/front room support. </li><li>Demonstrated problem-solving and decision-making capability.</li><li>Demonstrated technical writing skills.</li><li>Proven cross-functional leadership and project management experience.</li><li>Excellent verbal communication and presentation skills.</li><li>Previous LEAN experience.</li><li>Experience with electronic laboratory management systems such as LIMS, ELN and LES.</li><li>Experience with Climet instrumentation and MODA.</li></ul>Additional Information:<ul><li>Ability to work overtime as required.</li><li>Available off shift to respond to operational issues.</li><li>The position is for the Kenosha County, Wisconsin site. Onsite presence is required, but the position will allow for a flexible working environment with the ability to periodically work remotely (no more than 4 days per month) based on the project phase and site activities.</li><li>Position may require periodic business travel (~10-20%) to support site benchmarking initiatives, training needs and cross-site networking.</li></ul>This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.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 (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is$123,000 - $180,400<h3></h3>Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLilly

Eli Lilly

Associate Director, Quality Control - Microbiology US, Pleasant Prairie WI

Eli Lilly