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Eli Lilly and Company

Associate Director - Quality Assurance

Eli Lilly and Company, Indianapolis, Indiana, us, 46262

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Overview

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. Responsibilities

Associate Director – Quality Assurance (QA) API External Manufacturing: manage the activities of QA personnel supporting the oversight of externally manufactured Peptides and Intermediates. Balance coaching the QA staff with prioritization and staffing for routine production support activities, implementation of Quality projects, technology transfers, and commercialization. Oversee quality projects supporting API EM, support the productivity and development of QA staff, and ensure the quality of the API EM Tides portfolio manufactured by Contract Manufacturers (CM). Ensure the quality systems of the CM meet cGMPs and comply with Quality Agreements. Oversee department performance, resolve quality issues, and ensure overarching compliance. Maintain knowledge of cGMPs, global regulatory manufacturing guidance, and corporate/industry standards for product commercialization and production. Work cross-functionally within the site, with network and commercialization teams, and with global suppliers to deliver on business plans and quality objectives. Basic Qualifications

Bachelor’s Degree (Preferred: Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) 5+ years of experience in pharmaceutical manufacturing or development in areas such as TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences

Maintains a safe work environment Proven leadership, administrative, and organizational skills In-depth knowledge of cGMPs and regulatory expectations Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues within the site and function High attention to detail and a commitment to quality and compliance Builds relationships with internal and external customers and partners Proficiency in delivering highly complex, cross-functional tasks Demonstrated project management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills with a proactive approach Effective communication and influence across functional groups Strategic thinking to balance short-term needs with long-term business evolution Enthusiasm for change, team spirit, and flexibility Ability to learn and apply technical/scientific knowledge Additional Information

10 – 20% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across a global supplier network Accommodations and Equal Opportunity

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 at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals requesting accommodation as part of the application process; any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), and Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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. Full-time equivalent employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program, including 401(k) eligibility, pension, vacation benefits, medical/dental/vision and prescription drug coverage, flexible benefits, life insurance, time off and leave benefits, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly

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