Associate Director-QC Micro

3 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Associate Director - Quality Control leads all aspects of laboratory testing in support of manufacturing operations. This position requires the ability to multitask / prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate problems then develop and implement alternative solutions.

Responsibilities:

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Recruit / retain effective diverse staff; supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.Assist in the setting of human resource and business plan goals.Leadership role in implementation of quality systems.Apply knowledge of quality principles and GMPs toward the development of local procedures.Define and supervise quality plans for analytical projects to ensure accurate priority, resources, and direction have been provided.Interact effectively with customer and support groups.Define and maintain inspection readiness activities.Network with other areas to understand best practices, share knowledge, assist in tactical and strategic business planning, and to ensure customer needs are met.Interact with regulatory agencies during inspections regarding cGMP issues.Influence development of improved and streamlined quality systems.Serve as conduit for corporate communications / initiatives.Serve as technical resource and review and approve technical documents.Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability.Leadership role in Lean management system including supporting and acting as change agent, supporting and leading improvement initiatives and setting the example for a continuous improvement mentality.Network with other sites regarding new systems development.Develop plan for capital purchases.Facilitate the implementation of OSSCE concept, work closely with customers to ensure development of systems that will facilitate the workflow.Maintain open communications and promote teamwork and employee collaboration in the work group.

Basic Qualifications:

Bachelor of Science in Chemistry / Biology / Microbiology or related science.3+ years GMP laboratory experience

Additional Skills/Preferences:

Effective time managementDeep understanding of compliance requirements and regulatory expectationsEffective problem-solving skillsSix Sigma Green Belt or Black Belt certification.

Additional Information:

Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.Tasks may require repetitive motion (e.g., keyboarding).Ability to work 8-hour days - Monday through FridayAbility to work overtime as requiredAvailable off shift to respond to operational issuesMinimal travel required.

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 ( Lilly_Recruiting_Compliance@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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