Sr. Director - Quality Control Laboratories

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.

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 scientists 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
• Work 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

Basic 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

Additional Skills/Preferences

• 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

Additional Information

• Ability to travel (approximately 10%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at for further assistance.

Lilly is proud to be an 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.

Compensation: The anticipated wage for this position is $156,000 - $228,800. Full‑time employees will be eligible for a company bonus and a comprehensive benefit program including 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, leave of absence benefits, and well‑being benefits.

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