Associate - Qa- Idap Commercialization

Eli Lilly UK

Indianapolis, Indiana, US
Base: $65,250 - $169,400; bonus/equity: compyny bo...
Quality oversight for commercialization deliverables
Batch release for clinical trial and commercial materials
Regulatory submissions and response to questions
The role provides QA oversight for commercialization of the Indianapolis Device Assembly and Packaging product portfolio, ensuring smooth progression of products through the commercial pipeline

Job Summary

  • The role provides QA oversight for commercialization of the Indianapolis Device Assembly and Packaging product portfolio, ensuring smooth progression of products through the commercial pipeline.
  • Employees at Lilly benefit from a comprehensive compensation and benefits package including bonuses, 401(k), pension, medical, dental, vision, and well-being programs.
  • Lilly is committed to diversity, inclusion, and equal opportunity, supporting employee resource groups and providing accommodations for individuals with disabilities.

Matching Summary

The role provides QA oversight for commercialization of the Indianapolis Device Assembly and Packaging product portfolio, ensuring smooth progression of products through the commercial pipeline.

Salary

Base: $65,250 - $169,400; Bonus/Equity: Company bonus depending on performance; Benefits: Comprehensive benefits including 401(k), pension, medical, dental, vision, and well-being programs

Skills & Requirements

Must-have

  • Quality oversight for commercialization deliverables
  • Batch release for clinical trial and commercial materials
  • Regulatory submissions and response to questions
  • Process validations and technology transfers
  • Integrated Manufacturing Control Strategy development
  • Compliance with cGMP and global quality standards

Nice-to-have

  • Strong interpersonal and communication skills
  • Demonstrated leadership skills
  • Problem solving skills
  • Positive attitude and flexibility
  • Experience with biotech product regulations
  • Knowledge of FDA and EMA regulatory agencies

Key Requirements

  • Bachelor’s degree in scientific or technical field
  • Minimum 10 years pharmaceutical experience
  • Minimum 5 years quality experience
  • Authorized to work full-time in the United States

Work Rights

Authorized to work full-time in the United States

Tailored Resume

Cover Letter