Sr. Director - Quality Control Laboratories
Eli Lilly and Company
Summary
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Huntsville, Alabama. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the Lilly Site 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.
Job description
The Sr. Director – QC Laboratories will provide administrative leadership for the quality laboratories and ensure appropriate capabilities and business processes are developed at the site. The role will define and lead the organization that will support the quality control and analytical laboratories in support of the site and Lilly's growing pipeline. Within quality control, a state-of-the-art facility will utilize the latest in automation to further the analytical capabilities. These capabilities include everything from on-line in process testing through stability and ongoing process monitoring. The analytical capabilities team will consist of high-level scientist focused on the implementation/transfer of new modalities, proposal, and implementation analytical process improvements, along with the establishment of a center of excellence for molecule characterization. This position involves working cross functionally within the site and across the network to develop the strategic functional capabilities needed to support the mission of the site. The individual in this role must have expertise in analytical operations and quality systems and a demonstrated ability to develop and lead large teams, lead leaders within an organization, and influence across the networks and with global organizations.
Responsibilities
Business Support
- Build a high-quality organization in support of Quality Laboratory Operations
- Maintain GMP Compliance in all Laboratory Operations
- Deliver the lab of the future vision for LP1 including integrated digital, paperless processes
- Participate on the local area lead teams and Quality Lead Team
- Works closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems
- Exhibit critical business decision bringing about successful results
- Communicate to and strive for integration with support groups inside and outside the plant
- Coordinate laboratory related business planning and budget management
- Ensure safe work environment that complies with regulations
- Serve as a conduit for corporate communications as needed
Compliance Oversight
- Quality and compliance consistency across laboratories
- Coordinate and manage all regulatory and internal inspections
Personnel Development
- Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports
- Recruit new talent and develop site capabilities to deliver a high functioning QCL organization
- Ensure administrative and technical capability within the organization
Requirements
- Bachelor's degree in chemistry, microbiology, engineering, or related discipline
- Minimum of 10 years supporting complex analytical testing (chromatography, bioassay, and analytical characterization)
- 2+ years working in a GMP/cGMP environment
- 5+ years leadership experience
- Expertise in quality and compliance requirements for analytical laboratories
- Experience with regulatory submissions
- Proficiency with computer systems including Microsoft Office products
- Demonstrated technical writing ability
- Demonstrated strong oral and written communication
- Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally
- Demonstrated ability to maintain a safe work environment
- Ability to travel (approximately 10%)
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.