Sr. Director - Quality Control Laboratories

Lilly • Huntsville, AL

1d • $163,500 - $239,800

About The Position

Lilly is constructing an advanced manufacturing facility in Huntsville, Alabama, for production of API molecules. This greenfield site is intended to provide APIs for current and future products, including new modalities. The successful candidate will join the site leadership team and help build the organization, facility, and culture for startup into GMP manufacturing operations.

The Sr. Director – QC Laboratories provides administrative leadership for the quality laboratories and ensures the site develops appropriate capabilities and business processes. The role defines and leads the organization supporting quality control and analytical laboratories for the site and Lilly’s growing pipeline. The state-of-the-art quality control facility will use automation to expand analytical capabilities, from online in-process testing through stability and ongoing process monitoring. An analytical capabilities team will focus on implementing and transferring new modalities, proposing and implementing analytical process improvements, and establishing a center of excellence for molecule characterization.

The position works cross-functionally at the site and across Lilly’s network to develop strategic functional capabilities. The successful candidate brings expertise in analytical operations and quality systems, and a demonstrated ability to develop and lead large teams, lead leaders, and influence network and global organizations. The role requires approximately 10% travel.

Requirements

• Bachelor’s degree in chemistry, microbiology, engineering, or a related discipline.
• At least 10 years supporting complex analytical testing, including chromatography, bioassay, and analytical characterization.
• At least 2 years working in a GMP/cGMP environment.
• At least 5 years of 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.
• Strong oral and written communication skills.
• Interpersonal skills and the ability to lead leaders and influence cross-functionally and externally.
• 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 local area lead teams and the Quality Lead Team.
• Work with Global Quality Laboratories and Global QC Operations to ensure consistent, standardized approaches to laboratory organizational design, business processes, and systems.
• Make critical business decisions that lead to successful results.
• Communicate and work toward integration with support groups inside and outside the plant.
• Coordinate laboratory-related business planning and budget management.
• Ensure a safe work environment that complies with regulations.
• Serve as a conduit for corporate communications as needed.
• Promote quality and compliance consistency across laboratories.
• Coordinate and manage regulatory and internal inspections.
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.
• Recruit talent and develop site capabilities to deliver a high-functioning QCL organization.
• Ensure administrative and technical capability within the organization.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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