Principal/sr. Associate-qa-api External Manufacturing

Eli Lilly UK

Base: $65,250 - $169,400; bonus/equity: compyny bo...
**
Api em quality assurance
Cgmp compliance
Quality agreements
** Eli Lilly UK is seeking a Principal/Sr. Associate for API Quality Assurance in External Manufacturing, responsible for ensuring compliance with quality standards and regulatory requirements. The role requires at least two years of experience in GMP manufacturing and involves quality oversight at contract manufacturing organizations. **

Job Summary

  • The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs).
  • Serve as a liaison between CMs and Lilly, providing quality oversight and escalating quality issues.
  • Participate in regulatory inspection preparations, on-site support during inspections, and review/approve various quality documents.

Matching Summary

Match Score: 75

** Eli Lilly UK is seeking a Principal/Sr. Associate for API Quality Assurance in External Manufacturing, responsible for ensuring compliance with quality standards and regulatory requirements. The role requires at least two years of experience in GMP manufacturing and involves quality oversight at contract manufacturing organizations. **

Salary

Base: $65,250 - $169,400; Bonus/Equity: company bonus; Benefits: comprehensive benefit program

Skills & Requirements

Must-have

  • API EM Quality Assurance
  • cGMP compliance
  • Quality Agreements
  • regulatory inspection preparation
  • batch release documentation

Nice-to-have

  • coaching and mentoring skills
  • root cause analysis experience
  • statistical skills application
  • interpersonal and networking skills
  • influence diverse groups

Key Requirements

  • Bachelors degree in a science-related field
  • At least 2+ years GMP manufacturing experience
  • Authorized to work in the United States

Work Rights

Must be authorized to work full-time in the US

Tailored Resume

Cover Letter