Associate Director-Quality Control

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.

Organization Overview:

The Associate Director, Quality Control, will serve as site-based laboratory leadership supporting activities to include organizational design, staffing, procedures, and processes necessary to provide GMP lab testing in support of manufacturing operations. 

Responsibilities:
The Associate Director, Quality Control, will lead the Analytical Chemistry and Device testing teams, supporting continued start-up and routine operation of the Quality Control Laboratories at Lilly's Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.

• Serve as technical resource to review and approve technical documents 
• Work with the Lab Robotics and Lab IT areas for integrating future technology and systems, including LIMS
• Responsible for the strategy with focus on the site laboratory operations for the chemical and device testing labs
• Support recruiting and build capability, for a diverse leadership and lab staff to support the project and routine operations
• Maintain overall responsibility for establishing a QC Lab Operation  
• Ensure all aspects of safety are incorporated into lab processes and maintain a safe work environment, including supporting all HSE Corporate and Site Goals 
• Maintain a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including establishing lab practices, procedures, test methods, etc. 
• Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives 
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation 
• Ensure set up of all lab materials, chemicals, supplies, and services to support lab operation 
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group 
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment  
• Network with other areas to understand best practices, share knowledge, participate in tactical and strategic business planning, and ensure customer needs are met 
• Set QC Lab human resource and business plan goals
• Define and execute inspection readiness activities
• Interact with regulatory agencies during inspections regarding cGMP issues  
• Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability
• Ensure data integrity by design 

Basic Requirements:

• Bachelor of Science in Chemistry/Biology/Microbiology or related science 
• Previous pharmaceutical leadership experience including leading or working effectively with a cross functional group 
• 5+ years GMP lab experience including analytical testing and method transfer 

Additional Skills/Preferences:

• Deep understanding of compliance requirements and regulatory expectations 
• Excellent written and oral communication skills 
• Previous LEAN experience 
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems. 
• Strong technical aptitude and ability to train and mentor oth