Senior Director Quality Control

Senior Director – Quality Control at Eli Lilly and CompanyJoin to apply for the Senior Director Quality Control role at Eli Lilly and Company. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, with employees worldwide; we work to discover and bring life-changing medicines to those who need them and to support communities through philanthropy and volunteerism.Lilly is constructing an advanced manufacturing facility for production of APIs located in Lebanon, IN (Lilly Lebanon API). This facility represents Lilly’s largest investment in manufacturing capacity and supports current and future products, including new modalities. This is a unique opportunity to be part of the startup team for a greenfield manufacturing site, building processes and the facility to enable a successful startup into GMP manufacturing operations.Main Purpose And ObjectivesThe Senior Director – Quality Control is part of the Senior Leadership Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC Labs throughout the startup, implementation, and day-to-day operations of LP1. The Sr. Dir. – QC balances coaching a technical staff, prioritization and staffing for routine production support, implementation of technical projects, and process optimizations. The role requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry validation standards. The Sr. Dir. – QC will work cross-functionally within the site, network, commercialization teams, and other functions to deliver technical objectives, product business plans, and quality objectives. In the startup phase, the Sr. Dir. – QC will support project delivery, build a new organization, develop and implement necessary systems and business processes for GMP operations, and help shape the site culture. This will require collaboration, creativity, and resilience as the site grows to full-scale GMP operations.Key ResponsibilitiesProvide technical leadership, performance management, training and development of staffMaintain a safe work environmentEnsure GMP complianceEnsure technical review and approval for documents including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and morePartner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectivesInteract with regulators, customers, or outside stakeholders on business issues or for internal and external agency auditsEnsure adequate oversight and technical excellence for investigations and complaintsCollaborate with the site team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolioProvide oversight for technical projects to improve process control, capacity, yield, and qualityEnsure adequate technical representation and engagement within site and network governance meetings to influence technical agendasNetwork globally to share best practices and harmonize control strategies between sitesEngage and influence Pharmaceutical Product Development groups for applicable technical transfer deliverables for processes related to new molecule entities during commercializationMinimum RequirementsBachelor’s Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or related field10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environmentAdditional PreferencesAbility to influence and lead diverse groupsExperience with complex regulatory, business, or technical issues for pharmaceutical manufacturingStrong analytical and quantitative problem-solving skillsExperience with Empower softwareExperience with LIMS implementation and use within a manufacturing environmentExperience with statistical analysis of dataTechnical leadership, administrative and organizational skillsProficiency in delivering highly complex tasks and cross-functional tasksDemonstrated Project Management skills and ability to coordinate complex projectsAbility to communicate and influence across functional groups and stakeholdersStrategic thinking with the ability to balance short-term needs with long-term business evolutionAbility to build relationships with internal and external customers and partnersEnthusiasm for change, team spirit and flexibilityDemonstrated ability to learn and apply technical/scientific knowledgeAdditional InformationAbility to travel (approximately 10-20%)Onsite positionLilly is dedicated to helping individuals with disabilities to participate in the workforce and provides accommodations during the application process. If you require accommodation, please request via the accommodations process.Lilly is an Equal Employment Opportunity (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. #J-18808-Ljbffr