Sr. Director - Quality Control Laboratories

Lilly • Huntsville, AL

4d

About The Position

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.
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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Huntsvilles 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 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.

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

Nice To Haves

• 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

Responsibilities

• 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.
• Quality and compliance consistency across laboratories.
• Coordinate and manage all regulatory and internal inspections.
• 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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director