Senior Director - Pr&d Quality Systems

Lilly

Indianapolis, Indiana, US
$156,000 - $228,800; bonus eligible; comprehensive...
Pr&d quality system leadership
Gxp requirements interpretation
Clinical trial manufacturing quality
The PR&D Quality System Sr. Director provides critical technical leadership, leads optimization of the PR&D Quality System to ensure continuous improvement, maintain compliance in a changing regulatory landscape, and network with new R&D facilities for Quality System Integration

Job Summary

  • The PR&D Quality System Sr. Director provides critical technical leadership, leads optimization of the PR&D Quality System to ensure continuous improvement, maintain compliance in a changing regulatory landscape, and network with new R&D facilities for Quality System Integration.
  • Responsibilities include technical leadership of the PR&D Quality System as it relates to early phases of clinical manufacturing and supply, influencing and providing leadership within the broader PR&D organization, and communicating project information/quality issues to Quality Management.
  • Lilly offers a comprehensive benefit program including eligibility for a company-sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits, among others.

Matching Summary

The PR&D Quality System Sr. Director provides critical technical leadership, leads optimization of the PR&D Quality System to ensure continuous improvement, maintain compliance in a changing regulatory landscape, and network with new R&D facilities for Quality System Integration.

Salary

$156,000 - $228,800; Bonus eligible; Comprehensive benefits package

Skills & Requirements

Must-have

  • PR&D Quality System leadership
  • GxP requirements interpretation
  • Clinical Trial Manufacturing quality
  • Regulatory compliance
  • Continuous improvement initiatives

Nice-to-have

  • Strong communication skills
  • Cross-functional collaboration
  • Subject matter expertise
  • Independent and flexible work style
  • Building productive relationships

Key Requirements

  • Bachelor’s degree or equivalent work experience
  • 15+ years experience in CGMP manufacturing and supply
  • Experience in Early Phase CT manufacturing
  • Strong knowledge of cGMP requirements and GCP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter