Eli Lilly and Company

Senior Director – API Manufacturing Quality Assurance

Eli Lilly and Company

full-time

Posted on:

Location Type: Office

Location: Houston • Texas, Virginia • 🇺🇸 United States

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Salary

💰 $151,500 - $222,200 per year

Job Level

Senior

About the role

  • Serve as Site Quality Leader on the Lilly Site Lead Team
  • Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments
  • Lead the API Quality Team and manage its agenda
  • Support quality forums (e.g., Deviation and Change Control Boards)
  • Develop and monitor a site Quality Plan and metrics
  • Coordinate and manage regulatory inspections
  • Review and approve manufacturing and quality system documents
  • Ensure adequate QA staffing and provide coaching and development
  • Use HR tools for performance management, staffing, and succession planning
  • Contribute to QA business planning and site-wide strategic planning

Requirements

  • Bachelor's degree (STEM degree preferred)
  • 10+ years of pharmaceutical manufacturing quality experience
  • 5+ years of supervision/leadership experience
  • Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs
  • Proficient in statistical analysis and computer applications
  • Strong interpersonal, communication, and networking skills
  • Ability to influence diverse teams and manage multiple priorities
  • Demonstrated problem-solving and analytical thinking
Benefits
  • Health insurance
  • 401(k)
  • Pension
  • Vacation benefits
  • Medical benefits
  • Dental benefits
  • Vision benefits
  • Prescription drug benefits
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • Life insurance and death benefits
  • Time off and leave of absence benefits
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
cGMPstatistical analysisquality system documentationregulatory inspectionsquality metricsperformance managementsuccession planningpharmaceutical manufacturingquality assurance
Soft skills
leadershipinterpersonal skillscommunication skillsnetworking skillsproblem-solvinganalytical thinkinginfluencingmanaging priorities