Associate Director - Quality Control Laboratories

Eli Lilly and CompanyIndianapolis, IN
12dOnsite

About The Position

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.

Requirements

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

Nice To Haves

  • Effective time management
  • Deep understanding of compliance requirements and regulatory expectations
  • Effective problem-solving and teamwork skills.
  • Strong self-management and organizational skills.

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.
  • Ability to lead and manage complex change agendas in a fast-paced environment, while delivering on multiple priorities.
  • 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.
  • 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.
  • Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections.
  • Network with other sites regarding new systems development.
  • Work cross functionally at the site and global level to ensure recapitalization of equipment.
  • Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc.
  • Maintain open communications and promote teamwork and employee collaboration in the work group.

Benefits

  • 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).
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