Associate Director, Quality Control

Industry:

Company: Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 – $173,800

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 its 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 Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and QC laboratories.

The Associate Director, Quality Control, will provide administrative leadership for existing site quality control laboratories and ensure appropriate capabilities and business processes are developed and sustained. The role will lead the organization that will support both chemistry and microbiological analysis. 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 and advance the analytical technical agenda. The individual in this role must have expertise in Quality Control operations and quality systems.

Responsibilities:

• Work with cross-functional and global teams to drive delivery of full laboratory operations, including method, utilities, and equipment implementation.
• Work with the Site Quality Leader to support laboratory business and strategic planning to align with company, business unit and site goals.
• Lead talent acquisition initiatives for the laboratory to build a diverse team to support completion of laboratory implementation as well as sustained laboratory growth.
• Ensure all aspects of safety are incorporated into the lab and maintaining a safe work environment, including supporting all HSE Corporate and Site Goals.
• Establish a laboratory operation compliant with Lilly Global Quality Standards and regulatory requirements though development of effective processes, and through maintenance and monitoring of laboratory key performance indicators.
• Establish and maintain cross-site network to support alignment of site laboratory practices with global best practices.
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation.
• Management of laboratory costs, including management of purchase orders, approval of invoices and oversight of laboratory contractors and third-party entities.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Lead, coach, and aid in personnel development and performance management.
• Ensure a fair and equitable work environment.
• Lead and oversee regulatory and audit/inspection commitments, including annual product reviews, management reviews and audit/inspection responses.
• Interact with regulatory agencies during inspections regarding cGMP issues.

Basic Requirements:

• Bachelor’s degree in chemistry, microbiology, engineering, or related field
• A minimum of 5 years of leadership experience in Quality Control
• On-site presence required

Additional Skills/Preferences:

• Extensive knowledge and experience with compliance, compendial and regulatory requirements.
• Experience with regulatory inspections and audit readiness, including coaching of personnel and back room/front room support.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills.
• Proven cross-functional leadership and project management experience.
• Excellent verbal communication and presentation skills.
• Previous LEAN experience.
• Experience with electronic laboratory management systems such as LIMS, ELN and LES.

Additional Information:

• Flex hours possible
• Ability to work overtime as required.
• Available off shift to respond to operational issues.
• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10-20 %)

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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