Associate Director-Quality-Indianapolis Device Manufacturing Device Quality Cont

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.The Associate Director-Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible for quality control oversight of the Device Quality Laboratory.Responsibilities:Provide leadership of IDM Device Quality Control LabMentor, coach and provide feedback to team members and cross-functional partnersEnsure an adequate number of qualified resources are available to perform quality control activities in support of IDM QC Lab customersEnsure adherence to the quality policy and objectives for the siteProvide technical understanding and internal/external communication (throughout various functions and organization levels) regarding the Quality Management System to ensure on-going management of quality system requirements in order to maintain compliance and drive continuous improvement activitiesParticipate in and respond to regulatory agency and self-inspectionsReview/approve or reject procedures and training, technical protocol and reports, laboratory methods, change proposals, non-conformances and ensure implementation of appropriate corrections/CAPA and effectiveness checksParticipate in organizational and business planning activitiesExhibit cross-functional influenceIdentify barriers to productivity within the unit operation and drive continuous improvementSupport Method Transfers to Internal Lilly Sites and Contract ManufacturersProvide Management support to the internal Spec Management process in organizational and business planning activitiesPerform Site QC approval for laboratory investigationsOther duties as requiredBasic Requirements:Bachelor's degree in Engineering, Medical or Life SciencesMinimum of five (5) years industry related experience in areas which may include Quality, Technical Services, and/or ManufacturingDemonstrated leadership capabilityDemonstrated interpersonal skills for work with cross-functional teamsAbility to influence diverse groupsDemonstrated oral and written communicationDemonstrated self-management/time-management skillsMeets commitments and deadlinesDemonstrated decision-making and problem-solving skillsAbility to work as part of a teamNegotiating, mentoringAdditional Preferences:Knowledge of governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL)Regulatory inspection experienceTechnical knowledge in Quality System elements, devices, design, manufacturing and commissioning and qualificationLilly 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. 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$118,500 - $173,800Full-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