Associate, Internal Quality Control Operations

Lilly

Boston, MA, USA
Base: $71,250 - $161,700; bonus/equity: compyny bo...
Cgmp regulatory compliance knowledge
Analytical testing of gene therapy products
Leading oos and oot investigations
The role supports the discovery and delivery of life-changing medicines by ensuring product integrity through rigorous quality control operations

Job Summary

  • The role supports the discovery and delivery of life-changing medicines by ensuring product integrity through rigorous quality control operations.
  • Candidates will lead investigations into out-of-specification results and drive corrective actions to maintain compliance with FDA and ICH guidelines.
  • Employees receive a comprehensive benefit program including medical, dental, vision, 401(k) matching, and access to diverse employee resource groups.

Matching Summary

The role supports the discovery and delivery of life-changing medicines by ensuring product integrity through rigorous quality control operations.

Salary

Base: $71,250 - $161,700; Bonus/Equity: Company bonus eligible; Benefits: Medical, dental, vision, 401(k), vacation

Skills & Requirements

Must-have

  • cGMP regulatory compliance knowledge
  • analytical testing of gene therapy products
  • leading OOS and OOT investigations
  • method qualification and validation experience
  • training and mentoring QC analysts

Nice-to-have

  • experience with LIMS software systems
  • strong cross-functional collaboration skills
  • continuous improvement initiative leadership
  • audit preparation and response expertise

Key Requirements

  • Bachelor's degree in Chemistry or related field
  • Minimum 10 years QC experience in pharma/biotech
  • At least 2 years in a leadership or management role
  • Authorized to work in the United States without sponsorship

Work Rights

Must be authorized to work in the US on a full-time basis

Tailored Resume

Cover Letter