Sr. Director - Quality Control Laboratories

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Job 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 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.

Position Overview:

Lilly is actively growing it's manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result Lilly is looking for experienced quality control leaders to support our growth in the North Carolina area. This is a unique opportunity to deliver on new manufacturing investments and new state of the art QC laboratories. manufacturing operations.

The Sr. Director - QC Quality Control Laboratories will provide administrative leadership for site quality laboratories and ensure appropriate capabilities and business processes are developed and sustained. The role will lead the organization that will support the quality control laboratories in support of the site and Lilly's growing pipeline including chemistry and microbiological analysis. Within quality control, a state-of-the-art facility will utilize the latest in automation to further the analytical capabilities. 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 Quality Control operations and quality systems and a demonstrated ability to develop and lead large teams, lead leaders within an organization, and influence across 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
• Implement the lab of the future vision including integrated digital, paperless processes.
• Participate on the local area lead teams and Quality Lead Team.
• Work closely with Global Quality Analytical Sciences and QC Operations team 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 of support groups outside plant.
• Coordinate laboratory related business planning and budget management.
• Implement and sustain lean QC Operational Excellence principles
• 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
• A minimum of 10 years of leadership experience

Additional Skills/Preferences:

• Knowledge of QC operations, new product Introduction and process development support
• Expertise in quality and compliance requirements for analytical laboratories and regulatory requirements
• 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.

Additional Information:

• Flex hours possible
• Primary location is North Carolina
• 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 ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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