Senior Director Quality Control

Senior Director – Quality Control at Eli Lilly and Company

Join 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.

The 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.

• Provide technical leadership, performance management, training and development of staff
• Maintain a safe work environment
• Ensure GMP compliance
• Ensure 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 more
• Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
• Interact with regulators, customers, or outside stakeholders on business issues or for internal and external agency audits
• Ensure adequate oversight and technical excellence for investigations and complaints
• Collaborate 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 portfolio
• Provide oversight for technical projects to improve process control, capacity, yield, and quality
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas
• Network globally to share best practices and harmonize control strategies between sites
• Engage and influence Pharmaceutical Product Development groups for applicable technical transfer deliverables for processes related to new molecule entities during commercialization

• Bachelor’s Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or related field
• 10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment

• Ability to influence and lead diverse groups
• Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
• Strong analytical and quantitative problem-solving skills
• Experience with Empower software
• Experience with LIMS implementation and use within a manufacturing environment
• Experience with…