Drug Product Manufacturing Quality Assurance Specialist

1 mese fa


Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. As a leading innovator in the pharmaceutical industry, we're dedicated to discovering and bringing life-changing medicines to those who need them.

We're currently seeking a Drug Product Manufacturing Quality Assurance Specialist to join our team in ensuring the highest quality standards are met in our drug product external manufacturing operations. In this role, you will have the opportunity to oversee a wide range of quality activities, including initiating new partnerships and providing support for existing ones.

Main Responsibilities
  • Act as the primary Lilly quality contact for External Manufacturers (EMs)
  • Provide quality support for existing products and EMs, ensuring they follow appropriate quality systems
  • Build and maintain good communications with EMs and local Lilly affiliates
  • Participate in EM performance reviews and supply management

You will be responsible for ensuring that all quality-related activities are carried out in accordance with regulatory requirements and company policies. This includes performing batch dispositions, managing deviations and change controls, and investigating product quality complaints.

In addition, you will participate in the development of Annual Product Reviews (APRs) and Periodic Quality Evaluations (PQEs), and determine the appropriate stability program for products manufactured at EMs.

Required Skills and Qualifications
  • Bachelor's Degree in a technical background (Chemistry, Pharmacy, or similar)
  • Significant experience in technical and quality functions within a manufacturing plant, ideally in parenteral products (syringes and/or vials)
  • Appreciation of cultural diversity
  • Willingness to travel

A salary of $85,000 - $105,000 per year is estimated for this position, based on national averages in the United States. Please note that actual salaries may vary depending on location and other factors.



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