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 35,000 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.

Description

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 35,000 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

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Associate Director, Quality Control (Microbiology and Environmental Monitoring), will initially serve as the Quality Laboratory Project Lead responsible for start-up of the Quality Control Laboratories at Lilly's new Concord, North Carolina site. This role is responsible for leading the detailed lab design working in partnership with the Global Facilities Delivery (GFD) organization. As the project progresses, this role will transition to site-based laboratory leadership supporting readiness activities including organizational design, staffing, procedures, and processes necessary to provide GMP lab testing in support of manufacturing operations.

Responsibilities

The Associate Director, Quality Control (Microbiology and Environmental Monitoring), will lead the start-up and routine operation of the Microbiological and Environmental Monitoring Quality Control Laboratories at Lilly's Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as, project management.

• Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Maintain overall responsibility for establishing a QC Lab Operation
• Define and execute inspection readiness activities
• Set QC Lab human resource and business plan goals
• Support initial recruiting, build capability, for a diverse leadership and lab staff to support the qualification and startup of the lab operation
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation
• Ensure data integrity by design
• Interact with regulatory agencies during inspections regarding cGMP issues
• Network with other areas to understand best practices, share knowledge, participate in tactical and strategic business planning, and ensure customer needs are met
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
• Establish 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
• Ensure all aspects of safety are incorporated into the design and maintain a safe work environment, including supporting all HSE Corporate and Site Goals
• Work with the Lab Robotics and Lab IT areas for integrating future technology and systems into the delivery plan for startup or future use
• Ensure set up of all lab materials, chemicals, supplies, and services to support lab operation
• Act as GMP Lab Design Leader, working with Global Facility Delivery, Lilly project staff, and selected A&E firms to complete the detailed design of the lab area including the purchase and qualification of all laboratory instrumentation and equipment employing Quality by Design and Lean Lab principals
• Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the site laboratory operations for the microbiological and environmental monitoring testing labs
• Serve as technical resource to review and approve technical documents

Basic Requirements

• Minimum 5 years of pharmaceutical leadership experience including leading or working effectively with a cross functional groups
• Minimum 5 years GMP lab experience including microbiological testing, environmental monitoring, and method transfer
• Bachelor of Science in Biology/Microbiology or related work experience

Additional Skills/Preferences

• Experience with MODA
• Proven cross-functional leadership
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
• Project management experience
• Experience with LabVantage
• Strong technical aptitude and ability to train and mentor others
• Demonstrated problem-solving and decision-making capability
• Deep understanding of compliance requirements and regulatory expectations
• Excellent written and oral communication skills
• Previous LEAN experience

Additional Information

• Ability to work overtime as required
• Available off shift to respond to operational issues
• Ability to travel 10-30% of the time to support project phase
• Ability to support a short-term assignment (3-6 months) in Research Triangle Park or Indianapolis site
• Ability to work 8-hour days – Monday through Friday (On-site)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly