Director - QA IAPI

Lilly-posted 4 months ago
$118,500 - $173,800/Yr
Full-time • Mid Level
Indianapolis, IN
5,001-10,000 employees
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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.

  • Manage the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site.
  • Oversee the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service.
  • Ensure the department’s performance, resolution of quality issues, and regulatory compliance.
  • Develop and maintain processes that support inspections and audits; prepare individuals to interact with inspectors and auditors.
  • Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections.
  • Conduct performance management and development of QA staff.
  • Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives.
  • Provide coaching/feedback to and develop QA employees.
  • Utilize Human Resources tools to ensure that the right individuals are in the right job.
  • Participate in organizational planning.
  • Provide input into the business plan and ensure conformance to department budget for area of responsibility.
  • Exhibit cross-functional influence.
  • Maintain and improve quality systems.
  • Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes.
  • Participate in self assessments and regulatory agency inspections.
  • Ensure internal and external quality and supply commitments are met.
  • Provide quality management oversight for API manufacturing, laboratories and warehouses.
  • Investigate complaints.
  • Manage the creation, revision and maintenance of cGMP documents.
  • Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
  • 5+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.
  • Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs.
  • Excellent interpersonal skills and networking skills.
  • Ability to organize and prioritize multiple tasks.
  • Demonstrated strong problem solving and analytical thinking skills with strong attention to detail.
  • Demonstrated understanding of computer applications.
  • Demonstrated strong written and verbal communications skills.
  • Ability to influence and lead diverse groups; communicate and influence effectively across functional groups and stakeholders.
  • Understanding of statistical tools and analysis.
  • Previous experience supervising/leading people.
  • Demonstrated Project Management skills and ability to coordinate complex projects.
  • Strategic thinking and ability to balance short term needs with long term business evolution.
  • Enthusiasm for changes, team spirit and flexibility.
  • 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.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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