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.

Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection.  The Associate Director will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

Responsibilities:

Supporting the site to ensure a safe work environment including supporting and leading safety efforts for teamBuild a diverse and capable site organization to support quality oversight, and ensure compliance with area procedures and controls for parenteral operationsFoster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work groupDemonstrated administrative leadership of a diverse team including performance management and personnel development.Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan.Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.Ability to demonstrate flexibility with quick response as priorities change or issues arise.Support the development of the overall site operational readiness plan including establishment and reinforcement of quality processes and approval of operational proceduresWork cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue / deviation managementReview and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc.Partner with production and design organization to ensure 24/7 Quality oversight and supportEngage and support Operational Excellence initiatives for monitoring performance and continuously improving the operationNetwork with global and other parenteral network sites to understand best practices, share knowledge, and participate in tactical and strategic business planningSupport the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in parenteral productionActive communication on project and production status.Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections

Basic Requirements:

Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience.7 years of experience in a Quality role supporting pharmaceutical/medical device manufacturing.

Additional Skills/Preferences:

Experience working in the pharmaceutical industry in QA/QC rolesPrevious experience in parenteral production supportPrevious management or leadership experience including leading or working effectively with a cross functional groupStrong knowledge of Quality Management Systems and applicable regulatory requirementsPrevious experience directly supporting a pharmaceutical manufacturing operationExcellent interpersonal, written, and oral communication skillsStrong technical aptitude and ability to train and mentor othersPrevious facility or area start up experiencePrevious equipment qualification and process validation experiencePrevious experience with SAP or other inventory management systemsPrevious experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.Previous experience with Manufacturing Execution Systems and electronic batch releaseCQM, CQE, or CQA certification from the American Society for Quality (ASQ)Previous experience with deviation and change management systems including Trackwise

Additional Information:

Ability to work 8-hour days – Monday through FridayAbility to work overtime as requiredAbility to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations

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 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. Our 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), 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 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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