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, contributing to identifying and interpreting GxP requirements, and influencing the broader PR&D organization.
Lilly offers a comprehensive benefit program including 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: Company bonus (depending on performance); Benefits: Comprehensive benefit program
Skills & Requirements
Must-have
PR&D Quality System leadership
GxP requirements interpretation
Phase appropriate quality guidance
Continuous improvement identification
External regulatory decision monitoring
Cross-functional best practice implementation
Nice-to-have
Strong communication in multi-cultural settings
Subject matter expert recognition
Data synthesis for clear narrative
Independent and flexible work environment
Building productive relationships with leadership
Key Requirements
Bachelor's degree or equivalent work experience
15+ years in development and clinical cgmp manufacturing and supply