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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.

Organization Overview:

Eli Lilly and Company is dedicated to bringing innovation to patients and is growing its manufacturing operations significantly to meet the demand for our medicines. As a result, our Global Quality Analytical Sciences & QC Operations (AQCO) team is also growing.

The Associate Director, Analytical & QC Integrated Services (AQIS), will provide leadership to a team of individuals who will provides QA Oversight, and QC Compendial Affairs support to the organization.

The Associate Director is accountable for the successful operation of the internal laboratory infrastructure, quality systems and the Global Method & Specification Systems that support the analytical stewardship of Lilly products. The Associate Director provides leadership to the internal operations team and the network of Lilly laboratories that rely upon and interact with that team. This includes the oversight of internal standard operating procedures, equipment management, training, documentation, and deviation management systems. The manager serves as a Quality Assurance function and Chair for the AQCO. Also, QA and management for the Global Specifications and Methods Management and Compendial Affairs business processes across the Lilly network.

Detailed responsibilities:

• Direct and lead the operations component of the AQIS organization responsible for laboratory equipment and departmental standard operating procedure.

• Actively partners and collaborates with the other teams (Analytical and Laboratory Informatics, Forensics, etc.) to improve operational excellence of local and global business processes.

• Effectively partners with the laboratory network across M&Q and Regulatory Affairs to evaluate the technical and quality impact to global markets of compendial updates and develops appropriate implementation plans.

• Collaborates with the Quality Systems Team to ensure adequate Global Quality Standards exist to support the Global Method and Specification processes.

• The position will be responsible for development of implementation plans related to Global Laboratory Systems.

• Is accountable for providing the forecasted resource needs for maintaining the AQIS infrastructure (equipment/procedures/methods) in a state of compliance and audit readiness.

• The position will be accountable for managing the budget of their direct reports and predicting headcount resources to achieve the goals their direct organization.

• Provides Quality Assurance oversight to the AQCO which includes reviewing and approving deviations, change controls, analytical technical reports, method validation and method transfer protocols and summaries.

• Acts as Quality Lead Team Chair ensuring AQCO meets quality obligations by holding quarterly quality meetings and that management completes required reviews as to the Quality Compliance.

Basic Requirements:

• Bachelor's degree in chemistry, microbiology, engineering or applicable science related field of study or equivalent experience.

• Strong knowledge of cGMP and quality systems.

• Minimum of 10 years of technical and/or leadership experience in the pharmaceutical manufacturing GMP environment.

Additional Skills/Preferences:

• Experience in Quality Assurance and QC Compendial Affairs in a pharmaceutical manufacturing environment

• Knowledge in Quality Systems management

• Demonstrate ability to influence and lead of diverse team.

• Expertise with laboratory informatics applications such as Empower, LIMS, and eLN.

• Proficiency in planning and managing teams to carry out highly complex tasks and/or those that are highly cross-functional or cross-site in nature.

• Demonstrated ability to utilize and implement various tools, systems, and processes resulting in improved operational excellence of laboratory and business operations.

• Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.

• Demonstrated ability to interpret and apply solutions to different situations by understanding customer needs and applying strong problem-solving skills.

Additional Information:

• Ability to work 8-hour days – Monday through Friday, onsite, Indianapolis, LTC- North

• Ability to support processes outside of routine working hours, as needed.

• Ability to travel approximately 10% of the time.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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