Sr. Director - API Manufacturing Quality Control
BioSpace - Houston, TX
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Job DetailsAt 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.Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.Position OverviewThe Sr. Director - QC provides strategic and administrative leadership for the quality control and analytical sciences laboratories at a new Lilly API site. This role ensures the development of essential capabilities and business processes to support site operations and Lilly's expanding pipeline.ResponsibilitiesBusiness SupportBuild and lead a high-performing Quality Laboratory Operations teamEnsure GMP compliance across all lab activitiesDeliver the "lab of the future" vision with integrated digital, paperless processesCollaborate with local and global quality teams to standardize lab design, processes, and systemsParticipate in site and quality leadership teamsDrive strategic decisions and successful business outcomesCoordinate lab-related planning and budget managementPromote cross-functional integration and communicationMaintain a safe, compliant work environmentServe as a liaison for corporate communicationsCompliance OversightEnsure consistent quality and compliance across laboratoriesManage regulatory and internal inspectionsPersonnel DevelopmentLead HR planning, performance management, and talent developmentRecruit and build site capabilities for a high-functioning QC lab organizationEnsure strong administrative and technical leadership within the teamBasic QualificationsBachelor's degree in relevant field (STEM preferred)10+ years of supporting complex analytical testing (mass spec, bioassay, protein characterization)5+ years of supervisory/leadership experienceAdditional PreferencesKnowledge of QC operations, new product introduction, and process developmentExpertise in analytical lab quality and compliance requirementsExperience with regulatory submissionsProficient in Microsoft Office and other computer systemsStrong technical writing and communication skillsEffective interpersonal skills with ability to lead leaders and influence cross-functionallyCommitment to maintaining a safe work environmentLilly 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$151,500 - $222,200Full-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.#WeAreLillyCompanyScience has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.Company info Location 893 S Delaware St Indianapolis Indiana 46285 United StatesShare this job Facebook Twitter LinkedIn
Created: 2025-10-07